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FDA 510(k)

Rapid NCCT Stroke

K-Number: K222884 · 2023-03-02

ApplicantIschemaview, Inc.
Decision Date2023-03-02
Product CodeQAS
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Rapid NCCT Stroke is a medical device manufactured by Ischemaview, Inc.. It received FDA 510(k) clearance on 2023-03-02 under approval number K222884. 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 Rapid NCCT Stroke?

Rapid NCCT Stroke is a medical device that received FDA 510(k) clearance on 2023-03-02. It is manufactured by Ischemaview, Inc.. The 510(k) number is K222884.

When was Rapid NCCT Stroke approved by the FDA?

Rapid NCCT Stroke received FDA 510(k) clearance on 2023-03-02, under approval number K222884.

What company makes Rapid NCCT Stroke?

Rapid NCCT Stroke is manufactured by Ischemaview, Inc..

What is the FDA product code for Rapid NCCT Stroke?

The FDA product code for Rapid NCCT Stroke is QAS.

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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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