March 3, 2023

Canon Medical Systems Corporation

℅ Orlando Tadeo, Jr.
Sr. Manager, Regulatory Affairs
Canon Medical Systems USA, Inc.
2441 Michelle Drive
TUSTIN CA 92780

Re: K222819
Trade/Device Name: Aquilion Serve (TSX-307A/1) V1.2 with AiCE-i
Regulation Number: 21 CFR 892.1750
Regulation Name: Computed tomography x-ray system
Regulatory Class: Class II
Product Code: JAK
Dated: February 1, 2023
Received: February 2, 2023

Dear Orlando Tadeo:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced
above and have determined the device is substantially equivalent (for the indications for use stated in the
enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the
enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance
with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a
premarket approval application (PMA). You may, therefore, market the device, subject to the general
controls provisions of the Act. Although this letter refers to your product as a device, please be aware that
some cleared products may instead be combination products. The 510(k) Premarket Notification Database
located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination
product submissions. The general controls provisions of the Act include requirements for annual registration,
listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and
adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We
remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be
subject to additional controls. Existing major regulations affecting your device can be found in the Code of
Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements
concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA
has made a determination that your device complies with other requirements of the Act or any Federal
statutes and regulations administered by other Federal agencies. You must comply with all the Act's

U.S. Food & Drug Administration

10903 New Hampshire Avenue Doc ID# 04017.05.02
Silver Spring, MD 20993
www.fda.gov
K222819 - Orlando Tadeo, Jr. Page 2

requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803) for
devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see
https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-
combination-products); good manufacturing practice requirements as set forth in the quality systems (QS)
regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for
combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-
542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part
807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part
803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-
mdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including
information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-
devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn
(https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the
Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See
the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-
assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE
by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Lu Jiang
Lu Jiang, Ph.D.
Assistant Director
Diagnostic X-Ray Systems Team
DHT8B: Division of Imaging Devices
and Electronic Products
OHT8: Office of Radiological Health
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Enclosure
K222819
 K222819

510(k) SUMMARY

1. SUBMITTER’S NAME:
Fumiaki Teshima
Senior Manager, Quality Assurance Department
Canon Medical Systems Corporation
1385 Shimoishigami
Otawara-Shi, Tochigi-ken, Japan 324-8550

2. ESTABLISHMENT REGISTRATION:
9614698

3. OFFICIAL CORRESPONDENT/CONTACT PERSON:

Orlando Tadeo, Jr.
Sr. Manager, Regulatory Affairs
Canon Medical Systems USA, Inc
2441 Michelle Drive
Tustin, CA 92780
(714) 669-7459

4. DATE PREPARED:
September 16, 2022

5. TRADE NAME(S):
Aquilion Serve (TSX-307A/1) V1.2 with AiCE-i

6. COMMON NAME:
Computed Tomography X-ray System

7. DEVICE CLASSIFICATION:
a) Classification Name: Computed Tomography X-ray system
b) Regulation Number: 21 CFR §892.1750
c) Regulatory Class: Class II

8. PRODUCT CODE:
JAK

9. PERFORMANCE STANDARD:
This device conforms to applicable Performance Standards for Ionizing Radiation Emitting
Products [21 CFR, Subchapter J, Part 1020]

2441 Michelle Drive, Tustin, CA 92780 PHONE: 800-421-1968

https://us.medical.canon

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10. PREDICATE DEVICE:
Regulation Regulation 510(k) Clearance
Product Marketed by Product Code
Number Name Number Date
Primary Predicate:
JAK:
Aquilion Lightning Canon Computed
21 CFR System, X-ray,
(TSX-036A/7) V10.2 Medical Tomography K201836 01/12/2021
§892.1750 Tomography,
with AiCE-i Systems, USA X-ray System
Computed
Reference Predicate:
JAK:
Aquilion Prime SP Canon Computed
21 CFR System, X-ray,
(TSX-303B/8) V10.2 Medical Tomography K192832 02/21/2020
§892.1750 Tomography,
with AiCE-i Systems, USA X-ray System
Computed

11. REASON FOR SUBMISSION:

New medical device

12. DEVICE DESCRIPTION:

Aquilion Serve (TSX-307A/1) V1.2 with AiCE-i (Advanced intelligent Clear-IQ Engine-integrated) is a
whole body multi-slice helical CT scanner, consisting of a gantry, couch and a console used for data
processing and display. This device captures cross sectional volume data sets used to perform
specialized studies, using indicated software/hardware, by a trained and qualified physician. This
system is based upon the technology and materials of previously marketed Canon CT systems.

13. INDICATIONS FOR USE:

This device is indicated to acquire and display cross sectional volumes of the whole body, to include
the head. The Aquilion Serve has the capability to provide volume sets. These volume sets can be
used to perform specialized studies, using indicated software/hardware, by a trained and qualified
physician. AiCE (Advanced Intelligent Clear-IQ Engine) is a noise reduction algorithm that improves
image quality and reduces image noise by employing Deep Convolutional Neural Network methods
for abdomen, pelvis, lung, cardiac, extremities, head and inner ear applications.

14. SUBSTANTIAL EQUIVALENCE:

The Aquilion Serve (TSX-307A/1) V1.2 with AiCE-i is substantially equivalent to Aquilion Lightning
(TSX-036A/7) V10.2 with AiCE-i, which received premarket clearance under K201836, and is
marketed by Canon Medical Systems USA. The intended use of the Aquilion Serve is the same as
that of the predicate device.

A comparison of the technological characteristics between the subject and the predicate device is
included below.

Subject Device Predicate Device Comment

Device Name, Aquilion Serve Aquilion Lightning
Model Number (TSX-307A/1) V1.2 with AiCE-i (TSX-036A/7) V10.2 with AiCE-i
510(k) Number This submission K201836
Scan modes Conventional scan (Axial Scan*) Conventional scan (S&S, S&V) *: S&V is not
Volume, Dynamic volume scan Volume, Dynamic volume scan supported
Helical scan Helical scan S&S is called
“Axial Scan”

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 Subject Device Predicate Device Comment
Device Name, Aquilion Serve Aquilion Lightning
Model Number (TSX-307A/1) V1.2 with AiCE-i (TSX-036A/7) V10.2 with AiCE-i
510(k) Number This submission K201836
Positioning Scan Positioning: Scanoscopy:
Single Scano
Dual Dual Scano
3D Landmark Scan

3D Landmark Scan Available Not Available

Anatomical Available Not Available

Landmark
Detection
Scan planning assist Available Not Available *: If 3D Landmark
function* Scan is set in a
scan protocol.
Scan slice thickness [Conventional scan (Axial scan)] [Conventional scan (S&S, S&V)] *: Option
4-row scan: 0.5, 1, 2, 3, 4, 5, 8 4-row scan: 0.5, 1, 2, 3, 4, 5, 8,
mm 10 mm
1-row scan: 1 mm 1-row scan: 1 mm

[Volume, Dynamic volume scan] [Volume, Dynamic volume scan]

(80-row scan*: 0.5 mm) (80-row scan*: 0.5 mm)
40-row scan: 0.5 mm 40-row scan: 0.5 mm and 1 mm
4-row scan: 8 mm and 10 mm

[Helical scan] [Helical scan]

(80-row scan*: 0.5 mm) (80-row scan*: 0.5 mm)
40-row scan: 0.5 mm and 1 mm 40-row scan: 0.5 mm and 1 mm
20-row scan: 0.5 mm 20-row scan: 0.5 mm and 1 mm
4-row scan: 0.5 mm 4-row scan: 0.5 mm

[3D Landmark Scan]

40-row scan: 1.0 mm

Image Up to 30 images/s with AIDR 3D Up to 20 images/s with AIDR 3D *1: When the Fast
reconstruction time (0.033 s/image) (0.05 s/image) scan kit (CGS-
041A) is installed.
Up to 50 images/s with AIDR 3D Up to 50 images/s with AIDR 3D
*2: Option
(0.02 s/image)*1 (0.02 s/image) *2
When the Fast
Image
Reconstruction kit
Up to 70 images/s with AIDR 3D
(CCFR-010A) is
(0.014 s/image)*2
installed.
Up to 100 images/s with AIDR 3D *3: When the Fast
(0.01 s/image)*3 Image
Reconstruction kit
(Depending on the scan and (Depending on the scan and (CCFR-010A) and
reconstruction conditions) reconstruction conditions) the Fast scan kit
(CGS-041A) are
installed.
Flex e-Tilt Available Not Available

Page 3 of 7
 Subject Device Predicate Device Comment
Device Name, Aquilion Serve Aquilion Lightning
Model Number (TSX-307A/1) V1.2 with AiCE-i (TSX-036A/7) V10.2 with AiCE-i
510(k) Number This submission K201836
Gantry opening 800 mm in diameter 780 mm in diameter
diameter (aperture)

Wedge filter types Three (3) types Two (2) types *Previously
･ Small ･ Small cleared under
･ Large ･ Large K213504
･ SilverBeam Filter* (TSX-306A)
Gantry internal Available Not Available Two cameras
cameras mounted inside
the system at a
90-degree phase
difference.

Reconstruction Identified as anatomical regions* Identified as numbered *Previously

functions functions cleared under
K213504
(TSX-306A)
Noise reduction Adaptive Iterative Dose Adaptive Iterative Dose
processing Reduction 3D (AIDR 3D) Reduction 3D (AIDR 3D)

AIDR 3D Enhanced AIDR 3D Enhanced

Advanced Intelligent Clear-IQ Advanced Intelligent Clear-IQ

Engine (AiCE) Engine (AiCE)

Quantum Denoising Software

(QDS)

NewUX Console* Available Not Available *Previously

cleared under
K213504
(TSX-306A)
Display monitor 27 inch (3840 x 2160) 19 inch (1280 x 1024)

User Input Keyboard and Control Pad Scan Keyboard

(Performs scan operation and
controls voice messages)

Data processor CPU : 64-bit CPU : 64-bit

Memory size: 64 Gbyte or more Memory size: 32 Gbyte or more
Window width/level Controlled and continuously Controlled and continuously
variable using the mouse variable using a speed-sensitive
rotary encoder
Preset windows 1/image 3/image

Window types Linear only Linear and non-linear (6 user-

programmable), and double
windows
ROI shape available Point, Circular Point, square, free-form,
circular, polygon

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15. SAFETY:
The device is designed and manufactured under the Quality System Regulations as outlined in
21 CFR § 820 and ISO 13485 Standards. This device is in conformance with the applicable parts
of the following standards IEC60601-1, IEC60601-1-2, IEC60601-1-3, IEC60601-1-6, IEC60601-1-
9, IEC60601-2-28, IEC60601-2-44, IEC60825-1, IEC62304, IEC62366, NEMA XR-25, NEMA XR-26
and NEMA XR-29. Additionally, this device complies with all applicable requirements of the
radiation safety performance standards, as outlined in 21 CFR §1010 and §1020.

This device conforms to applicable Performance Standards for Ionizing Radiation Emitting
Products [21 CFR, Subchapter J, Part 1020]

16. TESTING
Risk analysis and verification/validation activities conducted through bench testing demonstrate
that the established specifications for the device have been met.

Performance Testing - Bench

Objective IQ Performance Comparison

An image quality metric evaluation comparing performance of the TSX-307A (Aquilion Serve)
system relative to the predicate device was conducted. In order to compare the image quality
between these two systems, the following image quality performance tests were conducted.
It was concluded that the subject device demonstrated equivalent or improved performance,
compared to the predicate device, as demonstrated by the results of the above testing.

1. Contrast-to-Noise Ratios (CNR)

2. CT Number Accuracy
3. Uniformity
4. Slice Sensitivity Profile (SSP)
5. Modulation Transfer Function (MTF)-Wire
6. Standard Deviation of Noise (SD)
7. Noise Power Spectra (NPS)
8. Low Contrast Detectability (LCD)

Image Quality Metric Evaluation

An image quality metric evaluation of Aquilion Serve (TSX-307A/1) V1.2 reconstructed
with AiCE, for the available Body, Body Sharp, Lung, Bone, Inner ear, Brain LCD, Brain
CTA and Cardiac modes was conducted and equivalent or improved image quality
performance relative to FBP and AIDR 3D was demonstrated. The following image
quality performance tests were conducted: Contrast-to-Noise Ratios (CNR), CT Number
Accuracy, Uniformity, Slice Sensitivity Profile (SSP), Modulation Transfer Function (MTF)-
Wire, Modulation Transfer Function (MTF)-Edge, Standard Deviation of Noise (SD),
Noise Power Spectra (NPS), Low Contrast Detectability (LCD), Pediatric.

AiCE Reconstruction for Lung Cancer Screening Image Quality Metric Evaluation
The performance of the subject device (Aquilion Serve with AiCE) was compared to the
results for the Aquilion ONE / GENESIS Edition with the AAPM lung cancer screening
protocol for both a small and a larger sized phantom. Please note the AAPM protocol

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does not use a fixed mA, but rather an automatic exposure setting of 20HU. Therefore,
the dose for the predicate device was determined by first establishing the AEC-
predicated dose for each phantom and then scanning with a fixed technique on the
GENESIS based on the result. The nearest fixed technique on the Serve was then
scanned. All results were reconstructed with AIDR (FC18 and FC52) as prescribed by the
AAPM protocol and were also reconstructed with AiCE DLR Body Sharp and AiCE Lung
and FBP FC18.

In order to compare the image quality between AiCE DLR on the Aquilion Serve and
Aquilion ONE / GENESIS Edition with AIDR (AAPM protocol), the following image quality
performance tests were conducted:

1. Contrast-to-Noise Ratios (CNR)

2. CT Number Accuracy
3. Uniformity
4. Slice Sensitivity Profile (SSP)
5. Modulation Transfer Function (MTF)-Edge
6. Standard Deviation of Noise (SD)
7. Noise Power Spectra (NPS)

It was concluded that the subject device demonstrated equivalent or improved

performance as demonstrated by the results of the above testing.

Automatic Scan Planning

Volunteer assessment demonstrated that couch movement appropriately positioned
volunteers to the selected anatomical region.

Flex e-Tilt
Image comparison studies were conducted between Flex e-Tilt reconstructed images
with the Aquilion Serve versus conventional tilt and MPR (oblique) images utilizing the
predicate device, Aquilion Lightning. It was determined that the images were equivalent
and there were no significant differences observed.

Noise Texture
An analysis of the NPS and kurtosis values for FBP, FIRST and AiCE was conducted and
the results of the study support the following claims, more natural noise texture
compared to FIRST, noise texture as natural as filtered backprojection, and noise texture
distinct from MBIR.

Quantitative Spatial Resolution

A comparison study was conducted, utilizing phantoms, in order to support a
quantitative spatial resolution improvement claim of twice the high contrast spatial
resolution for AiCE Body at 10% MTF and a 4.1 lp/cm increase in high contrast spatial
resolution for AiCE Cardiac at 10% MTF as compared to AIDR reconstruction.

Quantitative Body LCD and Noise Improvement and Dose Reduction

A phantom study was conducted using the MITA‐FDA LCD Body phantom and the
results demonstrated improved low contrast detectability at the same dose for AiCE
body compared to AIDR, noise reduction with AiCE at the same dose for body compared
to AIDR and dose reduction for AiCE Abdomen relative to FBP.

Page 6 of 7
 3D Scano Water Equivalence
A comparison phantom study was conducted utilizing a 24cm and 32cm water phantom
to demonstrate that both 3D Scano and dual scano produced 24cm and 32cm water
equivalent diameters with less than 5% mean absolute error.

Low Contrast Detectability Evaluation

A phantom study was conducted in order to support claims of low-contrast detectability
of 8.8 mGy (0.3%/3 mm) of AIDR3D, and 15.9mGy (0.3% / 2mm) and 8.1mGy (0.3% /
3mm) of AiCE, respectively.

Performance Testing – Clinical Images

Representative body, cardiac, chest, head, and extremity diagnostic images, reviewed by an
American Board-Certified Radiologist, were obtained using the subject device and it was
confirmed that the reconstructed images using the subject device were of diagnostic quality.

A summary of the risk analysis and verification/validation testing conducted through bench and
clinical testing is included in this submission which demonstrates that the requirements for the
system have been met.

Software Documentation for a Moderate Level of Concern, per the FDA guidance document,
“Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices
Document” issued on May 11, 2005, is included in this submission. This documentation includes
justification for the Moderate Level of Concern determination as well as testing which demonstrates
that the verification and validation requirements for the modifications described above have been
met.

A Software Information Checklist is included at the conclusion of this Executive Summary.

Cybersecurity documentation, per the FDA cybersecurity premarket guidance document “Content of
Premarket Submissions for Management of Cybersecurity in Medical Devices ” issued on October 2,
2014, is also included as part of this submission.

17. CONCLUSION
The Aquilion Serve (TSX-307A/1) V1.2 with AiCE performs in a manner similar to and is
intended for the same use as the predicate device, as indicated in product labeling. Based upon
this information, conformance to standards, successful completion of software validation,
application of risk management and design controls and the performance data presented in this
submission it is concluded that the subject device has demonstrated substantial equivalence to
the predicate device and is safe and effective for its intended use.

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