Rapid Aneurysm Triage and Notification— 510(k) K230074

Substantially Equivalent

Ischemaview, Inc.

FDA 510(k) clearance K230074 for Rapid Aneurysm Triage and Notification, Substantially Equivalent on 2023-07-27. Applicant: Ischemaview, Inc..

Clearance details

Applicant: Ischemaview, Inc.
Product code: Code QFM
Advisory panel: Radiology
Date received: 2023-01-10
Decision date: 2023-07-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Golden, CO, US

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