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FDA 510(k)

Aplio beyond and Aplio me Software V2.0 Diagnostic Ultrasound System

K-Number: K253597 · 2026-01-20

ApplicantCanon Medical Systems Corporation
Decision Date2026-01-20
Product CodeIYN
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Aplio beyond and Aplio me Software V2.0 Diagnostic Ultrasound System is the device name listed in this FDA 510(k) record. The listed applicant is Canon Medical Systems Corporation. It received FDA 510(k) clearance on 2026-01-20 under 510(k) number K253597. The device is classified under product code IYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Aplio beyond and Aplio me Software V2.0 Diagnostic Ultrasound System?

Aplio beyond and Aplio me Software V2.0 Diagnostic Ultrasound System is a medical device that received FDA 510(k) clearance on 2026-01-20. The listed applicant is Canon Medical Systems Corporation. The 510(k) number is K253597.

When did Aplio beyond and Aplio me Software V2.0 Diagnostic Ultrasound System receive FDA 510(k) clearance?

Aplio beyond and Aplio me Software V2.0 Diagnostic Ultrasound System received FDA 510(k) clearance on 2026-01-20, under 510(k) number K253597.

Who is the listed applicant for Aplio beyond and Aplio me Software V2.0 Diagnostic Ultrasound System?

The FDA 510(k) record lists Canon Medical Systems Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Aplio beyond and Aplio me Software V2.0 Diagnostic Ultrasound System?

The FDA product code for Aplio beyond and Aplio me Software V2.0 Diagnostic Ultrasound System is IYN.

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Other records listing Canon Medical Systems Corporation as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253596Aquilion ONE (TSX-308A/TSX-306A) V2.0K253625Vantage Fortian/Orian 1.5T, MRT-1550, V10.0 with AiCE Reconstruction Processing Unit for MRK260078Aquilion ServeSP (TSX-307B) V2.0K253584Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve Imaging (FOV Extension)K251370Cartesion Prime (PCD-1000A/3) V10.21K252074Aplio i900, Aplio i800 and Aplio i700 Software V9.0 Diagnostic Ultrasound System

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Related Devices (Code: IYN)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261668Venue GoGE Medical Systems Ultrasound and Primary care Diagnostics, LLCK262311Alturion Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLCK261835LOGIQ FocusGE Medical Systems Ultrasound and Primary Care DiagnosticsK261288Handheld Ultrasound ScannerIMGFAX CO., LTD.K261412V8/XV8/XH8/H8/cV8/V8 ONE/XV8 ONE/XH8 ONE/H8 ONE/cV8 ONE Diagnostic Ultrasound System; V7/XV7/XH7/H7/cV7/V7 ONE/XV7 ONE/H7 ONE/XH7 ONE/cV7 ONE Diagnostic Ultrasound System; V6/XV6/XH6/H6/cV6/V6 ONE/XV6 ONE/H6 ONE/XH6 ONE/cV6 ONE Diagnostic Ultrasound System; V5/XV5/XH5/H5/cV5 Diagnostic Ultrasound System; V4/XV4/XH4/H4/cV4 Diagnostic Ultrasound System;Samsung Medison Co., Ltd.K261211Philips EPIQ Series Diagnostic Ultrasound System; Philips Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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