Rapid RV/LV— 510(k) K223396

Substantially Equivalent

Ischemaview, Inc.

FDA 510(k) clearance K223396 for Rapid RV/LV, Substantially Equivalent on 2023-02-01. 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: 2022-11-08
Decision date: 2023-02-01
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.

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K243378 — Rapid MLS2025-05-28
K243350 — Rapid Neuro3D2025-01-22

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