Identity
- Trade Name
- iQ-SYSTEM PACS FDA UDI
- Generic Name
- Radiology picture archiving and communication system digital archive device FDA UDI
- Device Name
- iQ-SYSTEM PACS is a software device for network or web-based medical image viewing and manipulation. It is adapted for storing, processing, routing and reporting. FDA UDI
- Model / Reference
- 1.2 FDA UDI
- Description
- iQ-SYSTEM PACS is a software device for network or web-based medical image viewing and manipulation. It is adapted for storing, processing, routing and reporting. FDA UDI
Identifiers
- Primary DI / UDI-DI
- B403IQS120 FDA UDI
- 510(k) Number
- K062488 FDA UDI
- FDA Product Code
- LLZ FDA UDI
- GMDN Term
- Radiology picture archiving and communication system digital archive device FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.2050 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Radiology picture archiving and communication system digital archive device
iQ-SYSTEM PACS by IMAGE Information Systems Europe GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K062488 also covers:
- iQ-SYSTEM PACS — IMAGE Information Systems Europe GmbH
- iQ-SYSTEM PACS — IMAGE Information Systems Europe GmbH
- iQ-SYSTEM PACS — IMAGE Information Systems Europe GmbH
- iQ-SYSTEM PACS — IMAGE Information Systems Europe GmbH
- iQ-SYSTEM PACS — IMAGE Information Systems Europe GmbH
- iQ-SYSTEM PACS — IMAGE Information Systems Europe GmbH
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- IMAGE Information Systems Europe GmbH
Sources (1)
- FDA UDI 974cc429-fecb-4759-8dad-849951c570ea 34 fields · synced May 30, 2026