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Quantib AI Node 2.0

by Quantib B.V.

Quantib AI Node 2.0 is a Class II device made by Quantib B.V., cleared under FDA 510(k) K200899 on 15 Jun 2020, registered in EUDAMED and listed in FDA GUDID since 29 Oct 2020 (UDI-DI 08719689791049), active as of 23 Oct 2026.

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

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K200899

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number08719689791049 UDI-DI Date29 Oct 2020ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k) GUDID from GUDID NumberK200899 Date15 Jun 2020IssuedStatusActive
European UnionCE/MDR EUDAMED Number— Date—StatusActive

Official records

Across registries

3 registries list this device

  • FDA 510(k) K200899 decided 15 Jun 2020 Active
  • EUDAMED Active
  • FDA GUDID UDI-DI 08719689791049 listed 29 Oct 2020 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K200899
  2. Listed FDA GUDID 08719689791049

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  • Withdrawn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 AI Node
Generic name
Radiology DICOM image processing application software
Model / reference
2.0
Primary DI / UDI-DI
08719689791049
510(k) Number
FDA product code
LLZ
GMDN term
Radiology DICOM image processing application software
Device class
Class II
Regulation number
892.2050
GUDID distribution status
In Commercial Distribution

Related devices

Category: Radiology DICOM image processing application software

Cleared under the same submission (K200899)

Similar devices in this category

Other devices filed under Radiology DICOM image processing application software.

Other devices from Quantib B.V.

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    Class II

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    Class II

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    Class II

  • Quantib ND 2.2

    Class II

See all devices from Quantib B.V. →

Properties

  • Prescription use
  • Lot / batch number
Other properties (13, all answered No)