Skip to content

iQ-SYSTEM PACS 1.10

by IMAGE Information Systems Europe GmbH

iQ-SYSTEM PACS 1.10 is a Class II device made by IMAGE Information Systems Europe GmbH, cleared under FDA 510(k) K062488 on 19 Sep 2006 and listed in FDA GUDID since 19 Feb 2026 (UDI-DI B403IQS11004), 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) K062488

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 NumberB403IQS11004 UDI-DI Date19 Feb 2026ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK062488 Date19 Sep 2006DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K062488 decided 19 Sep 2006 Active
  • FDA GUDID UDI-DI B403IQS11004 listed 19 Feb 2026 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K062488
  2. Listed FDA GUDID B403IQS11004

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
iQ-SYSTEM PACS
Generic name
Radiology picture archiving and communication system digital archive device
Model / reference
1.10
Primary DI / UDI-DI
B403IQS11004
510(k) Number
FDA product code
LLZ
GMDN term
Radiology picture archiving and communication system digital archive device
Device class
Class II
Regulation number
892.2050
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K062488)

Similar devices

Other devices filed under FDA product code LLZ (System, Image Processing, Radiological).

Other devices from IMAGE Information Systems Europe GmbH

See all devices from IMAGE Information Systems Europe GmbH →

Properties

Other properties (15, all answered No)