Rapid (6.0)— 510(k) K233512

Substantially Equivalent

Ischemaview, Inc.

FDA 510(k) clearance K233512 for Rapid (6.0), Substantially Equivalent on 2024-01-16. 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: 2023-11-01
Decision date: 2024-01-16
Decision: Substantially Equivalent
Clearance type: Special
Location: Golden, CO, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code QIH

K260879 — 4DM2026-09-10
K261795 — Quicktome Software Suite2026-09-10
K251417 — ReVISION 22026-09-09
K260525 — NextMR Spine2026-09-04
K260811 — Heartvue.Proton2026-08-26

More clearances from Ischemaview, Inc.

K251987 — Rapid Aortic Measurements2025-09-23
K251533 — Rapid Obstructive Hydrocephalus, Rapid OH2025-09-04
K252526 — Rapid DeltaFuse2025-08-26
K243378 — Rapid MLS2025-05-28
K243350 — Rapid Neuro3D2025-01-22

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