FDA Registration
Active
🇩🇪 Germany
IMAGE INFORMATION SYSTEMS EUROPE GmbH
Reg #: 3006165530
·
FEI: 3006165530
·
Expires 2026
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- IMAGE INFORMATION SYSTEMS EUROPE GmbH
- Registration Number
- 3006165530
- FEI Number
- 3006165530
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Lange Strasse 16
- City
- ROSTOCK Mecklenburg-Western Pomerania
- Country
- DE
Regulatory Submissions
- 510(k) Number
- K062488
Owner / Operator
- Firm Name
- IMAGE Information Systems Europe GmbH
- Operator Number
- 9091611
- Address
- Lange Strasse 16
- City
- Rostock
- State
- Mecklenburg-Western Pomerania
- Postal Code
- 18055
- Country
- DE
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, Image Processing, Radiological | LLZ | Class 2 | Radiology | No | 2006-10-04 |
Proprietary Names
IQ-SYSTEM PACS
Establishment Types
Manufacture Medical Device