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QuantX Breast MRI

by Qlarity Imaging

QuantX Breast MRI (1) is a Class II device made by Qlarity Imaging, granted FDA De Novo DEN170022 on 19 Jul 2017 and listed in FDA GUDID since 19 Feb 2020 (UDI-DI B80711), active as of 23 Oct 2026.

Active United States. Also listed in GUDID (US).

De Novo

Valid until

No expiry

De Novo grant is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

De Novo DEN170022

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing NumberB80711 UDI-DI Date19 Feb 2020ListedStatusListed GUDID: in commercial distribution
United StatesFDA De NovoDENG from GUDID De Novo granted · Direct NumberDEN170022 Date19 Jul 2017DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA De Novo DEN170022 decided 19 Jul 2017 Active
  • FDA GUDID UDI-DI B80711 listed 19 Feb 2020 Listed

Timeline

2 dated events

  1. Granted FDA De Novo DEN170022
  2. Listed FDA GUDID B80711

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA De Novo Active

Specification

GUDID

Trade name
QuantX
Generic name
Radiological PACS-dedicated management software
Model / Ref / Catalog
Breast MRI, 1
Primary DI / UDI-DI
B80711
De Novo Number
FDA product code
POK
GMDN term
Radiological PACS-dedicated management software
Device class
Class II
Regulation number
892.2060
GUDID distribution status
In Commercial Distribution

Related devices

Category: Radiological PACS software

Similar devices in this category

Other devices filed under Radiological PACS software.

Other devices from Qlarity Imaging

Properties

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