Skip to content

Brain WMH

by Quantib B.V.

510(k) K251527

Brain WMH is a medical device (FDA Class II; FDA product code QIH, Automated Radiological Image Processing Software) made by Quantib B.V., cleared under FDA 510(k) K251527 on 25 Sep 2025, active as of 22 Oct 2026.

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK251527 Date25 Sep 2025ClearedStatusActive

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
QIH
Device class
Class II
Regulation
21 CFR Part 892.2050
Advisory committee
Radiology
FDA decision
SESE Substantially Equivalent

Similar devices

Other devices filed under FDA product code QIH (Automated Radiological Image Processing Software).

Other devices from Quantib B.V.

  • Quantib AI Node 2.4

    Class II

  • Quantib AI Node 2.2

    Class II

  • Quantib Prostate 2.0

    Class II

  • Quantib ND 2.2

    Class II

See all devices from Quantib B.V. →