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QuantX Breast MRI Biopsy Guidance Plugin

by Qlarity Imaging

QuantX Breast MRI Biopsy Guidance Plugin (2) is a Class II device made by Qlarity Imaging, cleared under FDA 510(k) K191959 on 8 Nov 2019 and listed in FDA GUDID since 27 Feb 2020 (UDI-DI B80721), active as of 23 Oct 2026.

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

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

510(k) K191959

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 NumberB80721 UDI-DI Date27 Feb 2020ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK191959 Date8 Nov 2019DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K191959 decided 8 Nov 2019 Active
  • FDA GUDID UDI-DI B80721 listed 27 Feb 2020 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K191959
  2. Listed FDA GUDID B80721

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
QuantX
Generic name
Radiological PACS-dedicated management software
Model / Ref / Catalog
Breast MRI Biopsy Guidance Plugin, 2
Primary DI / UDI-DI
B80721
510(k) Number
FDA product code
LLZ
GMDN term
Radiological PACS-dedicated management software
Device class
Class II
Regulation number
892.2050
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)