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Quantib B.V.

NetherlandsFDA applicant, unverified

Quantib B.V. is a medical device manufacturer, with 20 devices listed in FDA GUDID and FDA 510(k) (FDA Class II) as of 13 Nov 2026.

Devices
20

Registry facts

Counted by deviCERTS from registry records, 13 Nov 2026

Registries
  • FDA GUDID 15
  • FDA 510(k) 5

A device listed in two registries counts in both.

Device classes
  • FDA Class II 20
Identifiers
  • DUNS 490216247

What Quantib B.V. makes

Quantib B.V. makes radiology DICOM image processing application software and MRI system application software, including products such as Quantib AI Node, Quantib Prostate, Quantib ND, and Quantib Brain.

AI-generated from registry data, 29 Sep 2026. Not verified by deviCERTS or the manufacturer.

Catalogue20

Newest first, rows 1-20 of 20

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  • Quantib AI Node 2.4

    Active Regimes: 510(k) Registry: GUDID Class:II
  • Quantib Prostate 3.0

    Active Regimes: 510(k) Registry: GUDID Class:II
  • Quantib AI Node 2.2

    Active Regimes: 510(k) Registry: GUDID Class:II
  • Quantib Prostate 2.0

    Active Regimes: 510(k) Registry: GUDID Class:II
  • Quantib ND 2.2

    Active Regimes: 510(k) Registry: GUDID Class:II
  • Quantib ND 1.8

    Active Regimes: 510(k) Registry: GUDID Class:II
  • Quantib Prostate 1.2

    Active Regimes: 510(k) Registry: GUDID Class:II
  • Quantib Prostate 1.0

    Active Regimes: 510(k) Registry: GUDID Class:II
  • Quantib AI Node 2.3

    Active Regimes: 510(k) Registry: GUDID Class:II
  • Quantib Brain 1.4

    Active Regimes: 510(k) Registry: GUDID Class:II
  • Quantib Prostate 1.3

    Withdrawn Registry: GUDID Class:II
  • Quantib ND 1.5

    Active Regimes: 510(k) Registry: GUDID Class:II
  • Quantib Prostate 1.1

    Active Regimes: CE MDR 510(k) Registry: GUDID Class:II
  • Quantib ND 1.7

    Listed Registry: GUDID Class:II
  • Quantib AI Node 2.0

    Active Regimes: CE MDR 510(k) Registry: GUDID Class:II
  • Quantib Brain Ref K173939

    Active Regimes: 510(k) Registry: 510(k) Class:II
  • Quantib Brain 1.2 Ref K163013

    Active Regimes: 510(k) Registry: 510(k) Class:II
  • Quantib Brain 1 Ref K153351

    Active Regimes: 510(k) Registry: 510(k) Class:II
  • Brain WMH Ref K251527

    Active Regimes: 510(k) Registry: 510(k) Class:II
  • DeepHealth ProstateAI Ref K253682

    Active Regimes: 510(k) Registry: 510(k) Class:II

Rows 1-20 of 20

Company details

DUNS number
490216247

Frequently asked questions

How many devices does Quantib B.V. have in the registry?

The registry currently lists 20 devices for Quantib B.V.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Quantib B.V.'s devices?

Among its 20 most recently registered devices, Quantib B.V. has devices listed in FDA 510(k) (5 devices) and FDA GUDID (15 devices). A device can be listed in more than one registry, so these counts overlap.

What risk classes do Quantib B.V.'s devices fall under?

Among its 20 most recently registered devices, the classes recorded for Quantib B.V.'s devices are Class II. Each device page shows its own class and authorisation.

What are the newest devices from Quantib B.V. in the registry?

The most recently registered devices listed for Quantib B.V. include Quantib AI Node 2.4, Quantib Prostate 3.0, Quantib AI Node 2.2 and Quantib Prostate 2.0.

Generated automatically from registry data and not verified by a human reviewer.