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ProFound Pro 4.y.z

by Deephealth

ProFound Pro 4.y.z is a Class II device made by Deephealth, cleared under FDA 510(k) K251873 on 11 Aug 2025 and listed in FDA GUDID since 29 Jun 2026 (UDI-DI 00860005144051), 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) K251873

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 Number00860005144051 UDI-DI Date29 Jun 2026ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Special NumberK251873 Date11 Aug 2025DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K251873 decided 11 Aug 2025 Active
  • FDA GUDID UDI-DI 00860005144051 listed 29 Jun 2026 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K251873
  2. Listed FDA GUDID 00860005144051

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
ProFound Pro
Generic name
Radiology DICOM image processing application software
Model / reference
4.y.z
Primary DI / UDI-DI
00860005144051
510(k) Number
FDA product code
QDQ
GMDN term
Radiology DICOM image processing application software
Device class
Class II
Regulation number
892.2090
GUDID distribution status
In Commercial Distribution

Other devices from Deephealth

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Properties

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