Rapid PE Triage and Notification (PETN)— 510(k) K220499

Substantially Equivalent

Ischemaview, Inc.

FDA 510(k) clearance K220499 for Rapid PE Triage and Notification (PETN), Substantially Equivalent on 2022-05-17. Applicant: Ischemaview, Inc..

Clearance details

Applicant: Ischemaview, Inc.
Product code: Code QAS
Advisory panel: Radiology
Date received: 2022-02-22
Decision date: 2022-05-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Golden, CO, US

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