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FDA 510(k)

Aplio a550, Aplio a450, and Aplio a, Diagnostic Ultrasound System, Software V6.5

K-Number: K212960 · 2022-03-22

ApplicantCanon Medical Systems Corporation
Decision Date2022-03-22
Product CodeIYN
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Aplio a550, Aplio a450, and Aplio a, Diagnostic Ultrasound System, Software V6.5 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 2022-03-22 under 510(k) number K212960. 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 a550, Aplio a450, and Aplio a, Diagnostic Ultrasound System, Software V6.5?

Aplio a550, Aplio a450, and Aplio a, Diagnostic Ultrasound System, Software V6.5 is a medical device that received FDA 510(k) clearance on 2022-03-22. The listed applicant is Canon Medical Systems Corporation. The 510(k) number is K212960.

When did Aplio a550, Aplio a450, and Aplio a, Diagnostic Ultrasound System, Software V6.5 receive FDA 510(k) clearance?

Aplio a550, Aplio a450, and Aplio a, Diagnostic Ultrasound System, Software V6.5 received FDA 510(k) clearance on 2022-03-22, under 510(k) number K212960.

Who is the listed applicant for Aplio a550, Aplio a450, and Aplio a, Diagnostic Ultrasound System, Software V6.5?

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 a550, Aplio a450, and Aplio a, Diagnostic Ultrasound System, Software V6.5?

The FDA product code for Aplio a550, Aplio a450, and Aplio a, Diagnostic Ultrasound System, Software V6.5 is IYN.

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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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