November 21, 2023

Canon Medical Systems Corporation

℅ Yoshiaki Cook
Manager, Regulatory Affairs
Canon Medical Systems USA, Inc.
2441 Michelle Drive
TUSTIN CA 92780

Re: K232988
Trade/Device Name: Aplio flex and Aplio go Software V2.0 Diagnostic Ultrasound System
Regulation Number: 21 CFR 892.1550
Regulation Name: Ultrasonic Pulsed Doppler Imaging System
Regulatory Class: Class II
Product Code: IYN, IYO, ITX
Dated: September 21, 2023
Received: September 22, 2023

Dear Yoshiaki Cook:

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 (the 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
available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA
guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software
Change to an Existing Device" (https://www.fda.gov/media/99785/download).

U.S. Food & Drug Administration

10903 New Hampshire Avenue Doc ID# 04017.06.05
Silver Spring, MD 20993
www.fda.gov
K232988 - Yoshiaki Cook Page 2

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part
820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming
product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a
change requires premarket review, the QS regulation requires device manufacturers to review and approve
changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and
approvals in the device master record (21 CFR 820.181).

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
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 Part 803) for
devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart
A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections
531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR
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,

Yanna S. Kang -S
Yanna Kang, Ph.D.
Assistant Director
Mammography and Ultrasound Team
DHT8C: Division of Radiological Imaging
and Radiation Therapy Devices
OHT8: Office of Radiological Health
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Enclosure
 DEPARTMENT OF HEALTH AND HUMAN SERVICES Form Approved: OMB No. 0910-0120
Food and Drug Administration Expiration Date: 06/30/2023
Indications for Use See PRA Statement below.

510(k) Number (if known)

K232988
Device Name
Aplio flex and Aplio go Software V2.0 Diagnostic Ultrasound System

Indications for Use (Describe)

The Diagnostic Ultrasound System Aplio flex Model CUS-AFL00 and Aplio go Model CUS-AGG00 are indicated for the
visualization of structures, and dynamic processes with the human body using ultrasound and to provide image
information for diagnosis in the following clinical applications:
fetal, abdominal, pediatric, small organ (thyroid, breast and testicle), neonatal cephalic, adult cephalic, trans-rectal, trans-
vaginal, musculoskeletal (both conventional and superficial), cardiac, peripheral vascular, and thoracic/pleural.

This system provides high-quality ultrasound images in the following modes: B mode, M mode, Continuous Wave, Color
Doppler, Pulsed Wave Doppler , Power Doppler as well as Tissue Harmonic Imaging, Combined Modes and Acoustic
attenuation mapping.

This system is suitable for use in hospital and clinical settings by physicians or legally qualified persons who have
received the appropriate training.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.
*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*
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and review the collection of information. Send comments regarding this burden estimate or any other aspect
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“An agency may not conduct or sponsor, and a person is not required to respond to, a collection of
information unless it displays a currently valid OMB number.”

FORM FDA 3881 (6/20) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF
 K232988
510(k) SUMMARY

1. SUBMITTER’S NAME
Fumiaki Teshima
Sr. Manager, Quality Assurance Dept.
Quality, Safety and Regulation Center
Canon Medical Systems Corporation
1385 Shimoishigami
Otawara-shi, Tochigi-ken, Japan 324-8550

2. ESTABLISHMENT REGISTRATION
9614698

3. OFFICIAL CORRESPONDENT/CONTACT PERSON

Yoshiaki Cook
Manager, Regulatory Affairs
Canon Medical Systems USA, Inc.
2441 Michelle Drive
Tustin, CA 92780
ycook@us.medical.canon
+1 (657) 270-5595

4. DATE PREPARED
September 21, 2023

5. DEVICE NAME/TRADE NAME

Aplio flex and Aplio go Software V2.0 Diagnostic Ultrasound System

6. COMMON NAME
System, Diagnostic Ultrasound

7. DEVICE CLASSIFICATION
Class II
Ultrasonic Pulsed Doppler Imaging System – Product Code: 90-IYN [per 21 CFR 892.1550]
Ultrasonic Pulsed Echo Imaging System – Product Code: 90-IYO [per 21 CFR 892.1560]
Diagnostic Ultrasonic Transducer – Product Code: 90-ITX [per 21 CFR 892.1570]

______________________________________________________________________________________________________________________

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8. PREDICATE DEVICE

Product Marketed by 510(k) Number Clearance Date

Xario 200G/100G Diagnostic Canon Medical K182596 November 02, 2018
Ultrasound System, Software Systems USA, Inc.
Version 1.1 (Primary predicate)
Aplio i900/i800/i700 Diagnostic Canon Medical K223017 March 31, 2023
Ultrasound System, Software Systems USA, Inc.
V7.0 (Reference device)

9. REASON FOR SUBMISSION

New device.

10. DEVICE DESCRIPTION

The Aplio flex, Model CUS-AFL00 and Aplio go, Model CUS-AGG00, V2.0 are mobile diagnostic
ultrasound systems. These systems are Track 3 devices that employ an array of probes including
flat linear array, convex, and sector array with frequency ranges between approximately 2.5MHz to
12MHz.

11. INDICATIONS FOR USE

The Diagnostic Ultrasound System Aplio flex Model CUS-AFL00 and Aplio go Model CUS-AGG00 are
indicated for the visualization of structures, and dynamic processes with the human body using
ultrasound and to provide image information for diagnosis in the following clinical applications:
fetal, abdominal, pediatric, small organ (thyroid, breast and testicle), neonatal cephalic, adult
cephalic, trans-rectal, trans-vaginal, musculoskeletal (both conventional and superficial), cardiac,
peripheral vascular, and thoracic/pleural.

This system provides high-quality ultrasound images in the following modes: B mode, M mode,
Continuous Wave, Color Doppler, Pulsed Wave Doppler , Power Doppler as well as Tissue Harmonic
Imaging, Combined Modes and Acoustic attenuation mapping.

This system is suitable for use in hospital and clinical settings by physicians or legally qualified
persons who have received the appropriate training.

12. SUBSTANTIAL EQUIVALENCE

The subject devices, Aplio flex and Aplio go Software V2.0 Diagnostic Ultrasound System,
are substantially equivalent to the predicate devices, Xario 200G/100G Diagnostic Ultrasound
System, Software Version 1.1 (K182596).

The subject devices employ the same fundamental scientific technology as the predicate devices
and function in a manner similar to, and are intended for the same use as the predicate devices.
Differences between the subject devices and the cleared predicate devices do not raise any new
questions about the safety and effectiveness of the subject devices. This submission includes
evidence to demonstrate the substantial equivalence of the subject devices to the predicate
devices.

Page 2 of 4
• The subject and predicate devices have the same clinical intended use and imaging modes,
which differ only by the availability of Pencil Scan and CW Pencil Mode with the predicate
devices
o The indicated uses available with the subject devices are pre-existing with the
predicate devices, with the exception of the additional availability of
thoracic/pleural imaging with the subject devices
• The transducers newly developed for use with the subject devices employ the same
fundamental scientific technology and are substantially equivalent to those existing with
the predicate devices, while the remaining transducers supported by the subject devices
have been previously cleared with the predicate devices
• The software features supported in the subject and predicate devices are largely identical.
o The following features, previously cleared with reference devices, Aplio
i900/i800/i700 Diagnostic Ultrasound System, Software V7.0 (K223017), and which
are implemented into the subject devices, are not available with the predicate
devices:
 Attenuation Imaging, which enables the calculation and visualization of the
ultrasound frequency dependent attenuation coefficient
 Vascularity Index, which provides measurements based upon the
calculation of pixels within a Power image
 Lateral Gain, which enables the ability to adjust gain control from image
edge to edge
 ApliGate, which enables sharing of de-identified images from Aplio flex and
Aplio go
 Network Storage, which enables raw data to be stored to a Network
Attached Server (NAS)
 Tricefy Access, which enables DICOM images to be sent from Aplio flex and
Aplio go through a firewall to the Tricefy cloud server, a Class 1 medical
device
o The following features and/or functionality, previously cleared with the predicate
devices, are improved in the subject devices as follows:
 Trapezoid scan is now enabled for B mode and tilted scan for CDI, PDI, and
ADF
 QuickScan now enables the setting of PWD gate within the ROI, as well as
Doppler angle correction marker and angle oblique scan, in relation to flow
location and direction
 Mecha4D now enables OmniView image, a display of the transverse plane,
along the cutline set on an MPR image
 Luminance now supports transducer model PVU-674MVS
 Protocol Assistant now enables any cine/still image to be displayed as a
guide, previously acquired examination images to be displayed as
reference, and any user input text to be displayed
 Capability to hold an additional transducer, now up to a total of four
o The following features and/or functionality, which are available with the predicate
devices, are not implemented into the Aplio flex and Aplio go
 Superb Micro vascular Imaging (SMI); other Color Doppler image
processing features are equivalent between the subject and predicate
devices
 Auto IMT, a vascular measurement feature; other application
measurements are identical between the subject and predicate devices

Page 3 of 4
  2D Wall Motion Tracking, which enables myocardial wall motion analysis
by regional pattern matching in 2D cardiac images
 Contrast Imaging, Stress Echo, Shear Wave, and Elastography

14. SAFETY
The subject devices are designed and manufactured under the Quality System Regulations as
outlined in 21 CFR § 820 and ISO 13485 Standards. These devices are in conformance with the
applicable parts of the AAMI/ANSI ES60601-1: 2005/(R)2012 & A1:2012, C1:2009/(R)2012&
A2:2010/(R)2012 (Cons. Text) [Incl. AMD2:2021], IEC 60601-1-2:2020, IEC 60601-2-37:2015, IEC
62304:2015, IEC 62359:2017, and ISO 10993-1:2018 standards.

15. TESTING
Risk Analysis and verification and validation activities demonstrate that the established
specifications for these devices have been met. Additional performance testing included in the
submission was conducted in order to demonstrate that the requirements for the new features
were met. The results of all of these studies demonstrate that the subject devices meet
established specifications and perform as intended and in accordance with labeling.

FDA guidance document “Marketing Clearance of Diagnostic Ultrasound Systems and

Transducers”, issued February 21, 2023 was referenced for this submission, along with “Content
of Premarket Submissions for Device Software Functions” issued on June 14, 2023.

Additionally, cybersecurity documentation, per the FDA cybersecurity premarket guidance

document “Content of Premarket Submissions for Management of Cybersecurity in Medical
Devices” issued on October 02, 2014, is included in this submission.

Testing of these devices was conducted in accordance with the applicable standards published by
the International Electrotechnical Commission (IEC) for Medical Devices and UL systems.

16. CONCLUSION
The Aplio flex, Model CUS-AFL00 and Aplio go, Model CUS-AGG00, V2.0 are substantially
equivalent to the Xario 200G/100G Diagnostic Ultrasound System, Software Version 1.1, K182596.
The subject devices function in a manner similar to and are intended for the same use as the
predicate devices, as described in labeling. The evidence provided in this submission demonstrate
that Aplio flex, Model CUS-AFL00 and Aplio go, Model CUS-AGG00, V2.0 are safe and effective for
their intended use and perform with substantial equivalence to the predicate devices.

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