iQ-SYSTEM PACS 1.3
by IMAGE Information Systems Europe GmbH
iQ-SYSTEM PACS 1.3 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 5 Dec 2016 (UDI-DI B403IQS130), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | NumberB403IQS130 | Date5 Dec 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK062488 | Date19 Sep 2006 | StatusActive |
Official records
- FDA 510(k) database K062488
Across registries
- FDA 510(k) K062488 decided 19 Sep 2006 Active
- FDA GUDID UDI-DI B403IQS130 listed 5 Dec 2016 Listed
Timeline
- Cleared FDA 510(k) K062488
- Listed FDA GUDID B403IQS130
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- iQ-SYSTEM PACS
- Generic name
- Radiology picture archiving and communication system digital archive device
- Model / reference
- 1.3
- Primary DI / UDI-DI
- B403IQS130
- 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
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