Brain WMH— 510(k) K251527

Substantially Equivalent

Quantib B.V.

FDA 510(k) clearance K251527 for Brain WMH, Substantially Equivalent on 2025-09-25. Applicant: Quantib B.V.. Device class: 2.

Clearance details

Applicant: Quantib B.V.
Product code: Code QIH
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 2025-05-19
Decision date: 2025-09-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rotterdam, NL

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 Quantib B.V.

K253682 — DeepHealth ProstateAI2026-04-29
K230772 — Quantib Prostate2023-04-17
K221106 — Quantib Prostate2022-05-13
K213737 — Quantib ND2022-01-14
K202501 — Quantib Prostate2020-10-11

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