QP-Brain®— 510(k) K232231

Substantially Equivalent

Quibim S.L.

FDA 510(k) clearance K232231 for QP-Brain®, Substantially Equivalent on 2023-12-13. Applicant: Quibim S.L.. Device class: 2.

Clearance details

Applicant: Quibim S.L.
Product code: Code QIH
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 2023-07-27
Decision date: 2023-12-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Valencia, ES

Download summary PDF View on FDA.gov ↗

Recent devices under product code QIH

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K260525 — NextMR Spine2026-09-04
K260811 — Heartvue.Proton2026-08-26

More clearances from Quibim S.L.

K242683 — QP-Prostate® CAD2025-03-18
K203582 — QUIBIM Precision Prostate (qp-Prostate)2021-02-04

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