K243350

Substantially Equivalent

Rapid Neuro3D

Applicant: Ischemaview, Inc.
Product 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

Download summary PDF View on FDA.gov ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.