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PMD Viewer

by Spencer Technologies

PMD Viewer (12143) is a medical device (FDA Class II; FDA product code LLZ, System, Image Processing, Radiological) made by Spencer Technologies, cleared under FDA 510(k) K092204 on 8 Oct 2009 and listed in FDA GUDID since 4 Nov 2016 (UDI-DI 00862726000326), active as of 31 May 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 31 May 2026

Documents

510(k) K092204

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 31 May 2026.

Regulatory status

as of registry sync 31 May 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00862726000326 UDI-DI Date4 Nov 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK092204 Date8 Oct 2009DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K092204 decided 8 Oct 2009 Active
  • FDA GUDID UDI-DI 00862726000326 listed 4 Nov 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K092204
  2. Listed FDA GUDID 00862726000326

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Generic name
Radiology DICOM image processing application software
Model / Ref / Catalog
PMD Viewer, 12143
Primary DI / UDI-DI
00862726000326
510(k) Number
FDA product code
LLZ
GMDN term
Radiology DICOM image processing application software
Device class
Class II
Regulation number
892.2050
GUDID distribution status
In Commercial Distribution

Similar devices in this category

Other devices filed under Radiology DICOM image processing application software.

Other devices from Spencer Technologies

Properties

  • Prescription use
Other properties (14, all answered No)