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PACSgear Core Server 4.X

by Hyland LLC

PACSgear Core Server 4.X is a Class I device made by Hyland LLC, listed in FDA GUDID since 27 Dec 2019 (UDI-DI 00850677007167), registry data as of 22 Oct 2026.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00850677007167 UDI-DI Date27 Dec 2019ListedStatusListed GUDID: in commercial distribution

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade name
PACSgear Core Server
Generic name
Radiological PACS-dedicated management software
Model / reference
4.X
Primary DI / UDI-DI
00850677007167
FDA product code
OUG
GMDN term
Radiological PACS-dedicated management software
Device class
Class I
Regulation number
880.6310
GUDID distribution status
In Commercial Distribution

Related devices

Category: Radiological PACS softwareMedical image management system

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Properties

  • Premarket exempt
Other properties (14, all answered No)