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WorkstationOne™ 1.8.4

by Three Palm Software

WorkstationOne™ 1.8.4 is a Class II device made by Three Palm Software, cleared under FDA 510(k) K073272 on 11 Dec 2007 and listed in FDA GUDID since 15 Jun 2017 (UDI-DI B148WSONE1840), 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) K073272

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 NumberB148WSONE1840 UDI-DI Date15 Jun 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK073272 Date11 Dec 2007DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K073272 decided 11 Dec 2007 Active
  • FDA GUDID UDI-DI B148WSONE1840 listed 15 Jun 2017 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K073272
  2. Listed FDA GUDID B148WSONE1840

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
WorkstationOne™
Generic name
Radiology picture archiving and communication system workstation
Model / reference
1.8.4
Primary DI / UDI-DI
B148WSONE1840
510(k) Number
FDA product code
LLZ
GMDN term
Radiology picture archiving and communication system workstation
Device class
Class II
Regulation number
892.2050
GUDID distribution status
In Commercial Distribution

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Properties

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