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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 the device name listed in this FDA 510(k) record. The listed applicant is Infervision Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2021-08-12 under 510(k) 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. The listed applicant is Infervision Medical Technology Co., Ltd.. The 510(k) number is K211179.

When did InferRead CT Stroke.AI receive FDA 510(k) clearance?

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

Who is the listed applicant for InferRead CT Stroke.AI?

The FDA 510(k) record lists Infervision Medical Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Infervision Medical Technology Co., Ltd. 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.

K240554InferRead Lung CT.AI

Related Devices (Code: QAS)

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.

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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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