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Quantra 2.2

by Hologic

Ref SW-QT-AWS

Quantra 2.2 (R2LIC-2103-V2.2) is a medical device (EU MDR Class IIa; FDA Class II; FDA product code LLZ, System, image processing, radiological; EMDN category mammography systems - medical device software) made by Hologic, registered in EUDAMED on 13 Oct 2026 (Basic UDI-DI 54200455QUANTRANC), cleared under FDA 510(k) K163623 on 20 Oct 2017 and listed in FDA GUDID since 29 Jan 2019 (UDI-DI 15420045510319), active as of 24 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 24 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K163623

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number54200455QUANTRANC Basic UDI-DI 15420045510319UDI-DIDate13 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number15420045510319 UDI-DI Date29 Jan 2019ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK163623 Date20 Oct 2017DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 54200455QUANTRANC registered 13 Oct 2026 Active
  • FDA 510(k) K163623 decided 20 Oct 2017 Active
  • FDA GUDID UDI-DI 15420045510319 listed 29 Jan 2019 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K163623
  2. Listed FDA GUDID 15420045510319
  3. Registered EUDAMED 54200455QUANTRANC

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  • Withdrawn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
Quantra 2.2 Licese, AWS EUDAMED
Quantra GUDID
Generic name
Radiology DICOM image processing application software
Model / Ref / Catalog
SW-QT-AWS EUDAMED
2.2 GUDID
R2LIC-2103-V2.2 GUDID
Primary DI / UDI-DI
15420045510319
Basic UDI-DI
54200455QUANTRANC
Direct marketing DI
15420045510319
510(k) Number
FDA product code
LLZ
EMDN code
Z11030292 Mammography systems - medical device software
GMDN term
Radiology DICOM image processing 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
Belgium
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
SW-QT-AWS
GUDID
2.2
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.

Related devices

Category: Radiology DICOM image processing application software

Similar devices in this category

Other devices filed under MAMMOGRAPHY SYSTEMS - MEDICAL DEVICE SOFTWARE.

Other devices from Hologic

See all devices from Hologic →

Properties

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