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Eaglesoft 21.10

by Patterson Technology Center 6 variants

Eaglesoft 21.10 is a Class II device made by Patterson Technology Center, cleared under FDA 510(k) K982422 on 30 Sep 1998 and listed in FDA GUDID since 10 Apr 2020 (UDI-DI 00350227000292), 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) K982422

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 Number00350227000292 UDI-DI Date10 Apr 2020ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK982422 Date30 Sep 1998DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K982422 decided 30 Sep 1998 Active
  • FDA GUDID UDI-DI 00350227000292 listed 10 Apr 2020 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K982422
  2. Listed FDA GUDID 00350227000292

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Eaglesoft
Generic name
Radiological PACS-dedicated management software
Model / reference
21.10
Primary DI / UDI-DI
00350227000292, 00350227000254
510(k) Number
FDA product code
LLZ
GMDN term
Radiological PACS-dedicated management software
Device class
Class II
Regulation number
892.2050
GUDID distribution status
In Commercial Distribution

Similar devices in this category

Other devices filed under Radiological PACS software.

Other devices from Patterson Technology Center

  • Eaglesoft 19.10

    Class II
  • Eaglesoft 21.20

    Class II
  • Eaglesoft 18.10

    Class II
  • Eaglesoft 19.00

    Class II

See all devices from Patterson Technology Center →

Properties

  • Prescription use
  • Lot / batch number
  • Manufacturing date
Other properties (12, all answered No)