Quantib ND 2.2

by Quantib B.V.

Quantib ND 2.2 is a Class II device made by Quantib B.V., cleared under FDA 510(k) K213737 on 14 Jan 2022 and listed in FDA GUDID since 22 Jun 2023 (UDI-DI 08719689791261), 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	Number08719689791261 UDI-DI	Date22 Jun 2023Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k) from GUDID	NumberK213737	Date14 Jan 2022Issued	StatusActive

Official records

AccessGUDID record UDI-DI 08719689791261
FDA 510(k) database 510(k) number K213737

Across registries

2 registries list this device

FDA 510(k) K213737 decided 14 Jan 2022 Active
FDA GUDID UDI-DI 08719689791261 listed 22 Jun 2023 Listed

Timeline

2 dated events

14 Jan 2022 Cleared FDA 510(k) K213737
22 Jun 2023 Listed FDA GUDID 08719689791261

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name: Quantib ND
Generic name: MRI system application software
Model / reference: 2.2

Primary DI / UDI-DI: 08719689791261
510(k) Number: K213737
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)