Quantib Brain 1.4

by Quantib B.V.

Quantib Brain 1.4 is a Class II device made by Quantib B.V., cleared under FDA 510(k) K173939 on 9 Mar 2018 and listed in FDA GUDID since 6 Oct 2020 (UDI-DI 08719689791070), active as of 23 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

FDA submission, from GUDID

Trust

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number08719689791070 UDI-DI	Date6 Oct 2020Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK173939	Date9 Mar 2018Decided	StatusActive

Official records

AccessGUDID record UDI-DI 08719689791070
FDA 510(k) database 510(k) number K173939

Across registries

2 registries list this device

FDA 510(k) K173939 decided 9 Mar 2018 Active
FDA GUDID UDI-DI 08719689791070 listed 6 Oct 2020 Listed

Timeline

2 dated events

9 Mar 2018 Cleared FDA 510(k) K173939
6 Oct 2020 Listed FDA GUDID 08719689791070

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name: Quantib Brain
Generic name: MRI system application software
Model / reference: 1.4

Primary DI / UDI-DI: 08719689791070
510(k) Number: K173939
FDA product code: LLZ
GMDN term: MRI system application software

Device class: Class II
Regulation number: 892.2050
GUDID distribution status: In Commercial Distribution

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Properties

Prescription use
Lot / batch number

Other properties (13, all answered No)