Rapid ASPECTS (v3)— 510(k) K232156

Substantially Equivalent

Ischemaview, Inc.

FDA 510(k) clearance K232156 for Rapid ASPECTS (v3), Substantially Equivalent on 2024-01-19. Applicant: Ischemaview, Inc..

Clearance details

Applicant: Ischemaview, Inc.
Product code: Code POK
Advisory panel: Radiology
Date received: 2023-07-20
Decision date: 2024-01-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Golden, CO, US

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