Rapid Neuro3D— 510(k) K243350

Substantially Equivalent

Ischemaview, Inc.

FDA 510(k) clearance K243350 for Rapid Neuro3D, Substantially Equivalent on 2025-01-22. Applicant: Ischemaview, Inc..

Clearance details

Applicant: Ischemaview, Inc.
Product code: Code QIH
Advisory panel: Radiology
Date received: 2024-10-28
Decision date: 2025-01-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Golden, CO, US

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