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.. Device class: 2.

Clearance details

Applicant: Ischemaview, Inc.
Product code: Code QIH
Device class: Class 2
Regulation: 21 CFR 892.2050
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 ↗

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More clearances from Ischemaview, Inc.

K251987 — Rapid Aortic Measurements2025-09-23
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K243378 — Rapid MLS2025-05-28
K233582 — Rapid2024-04-22

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