Rapid CTA 360— 510(k) K251151

Substantially Equivalent

Ischemaview

FDA 510(k) clearance K251151 for Rapid CTA 360, Substantially Equivalent on 2025-07-16. Applicant: Ischemaview.

Clearance details

Applicant: Ischemaview
Product code: Code QAS
Advisory panel: Radiology
Date received: 2025-04-14
Decision date: 2025-07-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Golden, CO, US

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