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Quantib Brain 1.5

by Quantib BV

Ref 000-150

Quantib Brain 1.5 (000-150) is a device classified as Class IIa in the EU and Class II in the US made by Quantib BV, registered in EUDAMED on 22 Mar 2024 (Basic UDI-DI 8719689791PGNDQM) with CE/MDR certificate SCAR-13.2.2.1 valid until 1 Aug 2030, cleared under FDA 510(k) K173939 on 9 Mar 2018 and listed in FDA GUDID since 20 Mar 2024 (UDI-DI 08719689791254), active as of 22 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

1 Aug 2030

CE MDR certificate

FDA recalls

None found

in data synced 22 Oct 2026

Documents

1 certificate

Certifier Scarlet NB B.V.

510(k) K173939

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED NumberSCAR-13.2.2.1 Date26 May 2026IssuedStatusActive expires 1 Aug 2030
United StatesGUDID listing GUDID Number08719689791254 UDI-DI Date20 Mar 2024ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK173939 Date9 Mar 2018DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 8719689791PGNDQM registered 22 Mar 2024 Active· +1 more in the status table
  • FDA 510(k) K173939 decided 9 Mar 2018 Active
  • FDA GUDID UDI-DI 08719689791254 listed 20 Mar 2024 Listed

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • SCAR-13.2.2.1 Active Amended

    Quality management system EU MDR

    Certifier
    Scarlet NB B.V. 3022
    Issued
    26 May 2026
    Expires
    1 Aug 2030
    Reason
    Other

Timeline

5 dated events

  1. Cleared FDA 510(k) K173939
  2. Listed FDA GUDID 08719689791254
  3. Registered EUDAMED 8719689791PGNDQM
  4. Certificate issued EUDAMED SCAR-13.2.2.1
  5. Certificate expires EUDAMED SCAR-13.2.2.1

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
Quantib Brain 1.5 EUDAMED
Quantib Brain GUDID
Generic name
MRI system application software
Device name
Quantib ND
Model / reference
000-150 EUDAMED
1.5 GUDID
Primary DI / UDI-DI
08719689791254
Basic UDI-DI
8719689791PGNDQM
Direct marketing DI
08719689791254
510(k) Number
FDA product code
LLZ
EMDN code
Z119082 Various bioimaging and radiotherapy instruments - software accessories
GMDN term
MRI system application software
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
892.2050
Special device type
Software
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
000-150
GUDID
1.5
Device classEUDAMED
Class IIa
GUDID
Class II

Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Manufacturer details

EUDAMED SRN
NL-MF-000027601

Similar devices in this category

Other devices filed under VARIOUS BIOIMAGING AND RADIOTHERAPY INSTRUMENTS - SOFTWARE ACCESSORIES.

Other devices from Quantib BV

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Properties

  • Prescription use
  • Lot / batch number
Other properties (23, all answered No)