Rapid NCCT Stroke— 510(k) K222884

Substantially Equivalent

Ischemaview, Inc.

FDA 510(k) clearance K222884 for Rapid NCCT Stroke, Substantially Equivalent on 2023-03-02. Applicant: Ischemaview, Inc..

Clearance details

Applicant: Ischemaview, Inc.
Product code: Code QAS
Advisory panel: Radiology
Date received: 2022-09-22
Decision date: 2023-03-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Golden, CO, US

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