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FDA 510(k)

Aplio a550, Aplio a450, Aplio a, Diagnostic Ultrasound System, Software V5.1

K-Number: K202364 · 2020-10-15

ApplicantCanon Medical Systems Corporation
Decision Date2020-10-15
Product CodeIYN
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Aplio a550, Aplio a450, Aplio a, Diagnostic Ultrasound System, Software V5.1 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 2020-10-15 under 510(k) number K202364. 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, Aplio a, Diagnostic Ultrasound System, Software V5.1?

Aplio a550, Aplio a450, Aplio a, Diagnostic Ultrasound System, Software V5.1 is a medical device that received FDA 510(k) clearance on 2020-10-15. The listed applicant is Canon Medical Systems Corporation. The 510(k) number is K202364.

When did Aplio a550, Aplio a450, Aplio a, Diagnostic Ultrasound System, Software V5.1 receive FDA 510(k) clearance?

Aplio a550, Aplio a450, Aplio a, Diagnostic Ultrasound System, Software V5.1 received FDA 510(k) clearance on 2020-10-15, under 510(k) number K202364.

Who is the listed applicant for Aplio a550, Aplio a450, Aplio a, Diagnostic Ultrasound System, Software V5.1?

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, Aplio a, Diagnostic Ultrasound System, Software V5.1?

The FDA product code for Aplio a550, Aplio a450, Aplio a, Diagnostic Ultrasound System, Software V5.1 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.

K261617Diagnostic Ultrasound System (Resona I10W);Diagnostic Ultrasound System (Resona I10 Exp);Diagnostic Ultrasound System (Resona I10);Diagnostic Ultrasound System (Resona I10S);Diagnostic Ultrasound System (Resona XI);Diagnostic Ultrasound System (Resona I10 CV);Diagnostic Ultrasound System (Nuewa I10W);Diagnostic Ultrasound System (Nuewa I10 Exp);Diagnostic Ultrasound System (Nuewa I10);Diagnostic Ultrasound System (Nuewa I10S);Diagnostic Ultrasound System (Nuewa XI);Diagnostic UltrasounShenzhen Mindray Bio-Medical Electronics Co., Ltd.K263150V10 Diagnostic Ultrasound System; cV10 Diagnostic Ultrasound System; H10 Diagnostic Ultrasound System; XV10 Diagnostic Ultrasound System; XH10 Diagnostic Ultrasound System; V10 ONE Diagnostic Ultrasound System; cV10 ONE Diagnostic Ultrasound System; H10 ONE Diagnostic Ultrasound System; XV10 ONE Diagnostic Ultrasound System; XH10 ONE Diagnostic Ultrasound System; HERA Z10 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.K261933Voluson Expert 18; Voluson Expert 20; Voluson Expert 22GE Medical Systems Ultrasound and Primary care Diagnostics, LLCK262548EPIQ Inspira Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLCK263182EVO X30 Diagnostic Ultrasound System; EVO X20 Diagnostic Ultrasound System; EVO X10 Diagnostic Ultrasound System; EVO XP30 Diagnostic Ultrasound System; EVO XP20 Diagnostic Ultrasound System; EVO XP10 Diagnostic Ultrasound System; EVO XC30 Diagnostic Ultrasound System; EVO XC20 Diagnostic Ultrasound System; EVO XC10 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.K261313Vivid Explorer/Vivid Advanced/Vivid FocusGE Medical Systems Ultrasound and Primary Care Diagnostics

Official Source

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

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