Rapid SDH— 510(k) K232436

Substantially Equivalent

Ischemaview, Inc.

FDA 510(k) clearance K232436 for Rapid SDH, Substantially Equivalent on 2023-10-25. Applicant: Ischemaview, Inc..

Clearance details

Applicant: Ischemaview, Inc.
Product code: Code QAS
Advisory panel: Radiology
Date received: 2023-08-14
Decision date: 2023-10-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Golden, CO, US

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