Skip to content

Mammo Dx 5.y.z

by Deephealth

Mammo Dx 5.y.z is a Class II device made by Deephealth, cleared under FDA 510(k) K253825 on 15 Jun 2026 and listed in FDA GUDID since 7 Jul 2026 (UDI-DI 00860014963704), active as of 22 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 22 Oct 2026

Documents

510(k) K253825

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00860014963704 UDI-DI Date7 Jul 2026ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK253825 Date15 Jun 2026DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K253825 decided 15 Jun 2026 Active
  • FDA GUDID UDI-DI 00860014963704 listed 7 Jul 2026 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K253825
  2. Listed FDA GUDID 00860014963704

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Mammo Dx
Generic name
X-ray image interpretive software
Model / reference
5.y.z
Primary DI / UDI-DI
00860014963704
510(k) Number
FDA product code
QDQ
GMDN term
X-ray image interpretive software
Device class
Class II
Regulation number
892.2090
GUDID distribution status
In Commercial Distribution

Other devices from Deephealth

See all devices from Deephealth →

Properties

  • Lot / batch number
Other properties (14, all answered No)