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FDA 510(k)

Aplio a550, Aplio a450 and Aplio a, Diagnostic Ultrasound System, V4.0

K-Number: K191663 · 2019-09-18

Decision Date2019-09-18
Product CodeIYN
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Aplio a550, Aplio a450 and Aplio a, Diagnostic Ultrasound System, V4.0 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 2019-09-18 under 510(k) number K191663. 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, V4.0?

Aplio a550, Aplio a450 and Aplio a, Diagnostic Ultrasound System, V4.0 is a medical device that received FDA 510(k) clearance on 2019-09-18. The listed applicant is Canon Medical Systems Corporation. The 510(k) number is K191663.

When did Aplio a550, Aplio a450 and Aplio a, Diagnostic Ultrasound System, V4.0 receive FDA 510(k) clearance?

Aplio a550, Aplio a450 and Aplio a, Diagnostic Ultrasound System, V4.0 received FDA 510(k) clearance on 2019-09-18, under 510(k) number K191663.

Who is the listed applicant for Aplio a550, Aplio a450 and Aplio a, Diagnostic Ultrasound System, V4.0?

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, V4.0?

The FDA product code for Aplio a550, Aplio a450 and Aplio a, Diagnostic Ultrasound System, V4.0 is IYN.

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.

View all 97 devices →

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.

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.