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FDA 510(k)

InferRead CT Stroke.AI

K-Number: K211179 · 2021-08-12

ApplicantInfervision Medical Technology Co., Ltd.
Decision Date2021-08-12
Product CodeQAS
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

InferRead CT Stroke.AI is a medical device manufactured by Infervision Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2021-08-12 under approval number K211179. The device is classified under product code QAS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the InferRead CT Stroke.AI?

InferRead CT Stroke.AI is a medical device that received FDA 510(k) clearance on 2021-08-12. It is manufactured by Infervision Medical Technology Co., Ltd.. The 510(k) number is K211179.

When was InferRead CT Stroke.AI approved by the FDA?

InferRead CT Stroke.AI received FDA 510(k) clearance on 2021-08-12, under approval number K211179.

What company makes InferRead CT Stroke.AI?

InferRead CT Stroke.AI is manufactured by Infervision Medical Technology Co., Ltd..

What is the FDA product code for InferRead CT Stroke.AI?

The FDA product code for InferRead CT Stroke.AI is QAS.

Other Devices by Infervision Medical Technology Co., Ltd.

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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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