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 a medical device manufactured by Canon Medical Systems Corporation. It received FDA 510(k) clearance on 2026-01-20 under approval 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. It is manufactured by Canon Medical Systems Corporation. The 510(k) number is K253597.

When was Aplio beyond and Aplio me Software V2.0 Diagnostic Ultrasound System approved by the FDA?

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

What company makes Aplio beyond and Aplio me Software V2.0 Diagnostic Ultrasound System?

Aplio beyond and Aplio me Software V2.0 Diagnostic Ultrasound System is manufactured by Canon Medical Systems Corporation.

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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Related PubMed Literature

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Other Devices by Canon Medical Systems Corporation

K182601Vitrea Software Package, VSTP-001A K183013Vitrea Software Package, VSTP-001A K181646Celesteion, PCA-9000A/3, V6.5 K182596Xario200G and Xario100G, Software V1.1 Diagnostic Ultrasound System K182427Aplio a550 and a450, Software V2.8 Diagnostic Ultrasound System K182679Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V3.1

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Related Devices (Code: IYN)

K162845DC-40/DC-35/DC-45/DC-40S/DC-40 Pro Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. K162902ARIETTA Prologue Diagnostic Ultrasound system and TransducersHitachi , Ltd. K163138Clarius Ultrasound SystemClarius Mobile Health Corp. K163077LOGIQ E9, LOGIQ E9 XDClear 2.0GE Medical Systems Ultrasound and Primary Care Diagnostics K162583ALOKA LISENDO 880Hitachi , Ltd. K163020Xperius Ultrasound SystemPhilips Health Care

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.