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FDA 510(k)

AccuICAS

K-Number: K221711 · 2023-02-28

ApplicantArteryFlow Technology Co., Ltd.
Decision Date2023-02-28
Product CodeQHA
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

AccuICAS is a medical device manufactured by ArteryFlow Technology Co., Ltd.. It received FDA 510(k) clearance on 2023-02-28 under approval number K221711. The device is classified under product code QHA. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AccuICAS?

AccuICAS is a medical device that received FDA 510(k) clearance on 2023-02-28. It is manufactured by ArteryFlow Technology Co., Ltd.. The 510(k) number is K221711.

When was AccuICAS approved by the FDA?

AccuICAS received FDA 510(k) clearance on 2023-02-28, under approval number K221711.

What company makes AccuICAS?

AccuICAS is manufactured by ArteryFlow Technology Co., Ltd..

What is the FDA product code for AccuICAS?

The FDA product code for AccuICAS is QHA.

Other Devices by ArteryFlow Technology Co., Ltd.

K210093AccuFFRangio K220663AccuCTP K213838AneuGuide K231353AccuCTP Pro K230303AccuFFRangio Plus

Related Devices (Code: QHA)

K182611Qangio XA 3DMedis Medical Imaging Systems BV K210093AccuFFRangioArteryFlow Technology Co., Ltd. K230303AccuFFRangio PlusArteryFlow Technology Co., Ltd. K232147CAAS WorkstationPie Medical Imaging BV K251355X1-FFRSpectrawave, Inc. K243769QFR (3.0)Qfr Solutions BV

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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