Data / Medical devices / Germany / IMAGE INFORMATION SYSTEMS EUROPE GmbH
IMAGE INFORMATION SYSTEMS EUROPE GmbH: FDA-registered device maker in ROSTOCK Mecklenburg-Western Pomerania, Germany, 1 510(k) clearance
IMAGE INFORMATION SYSTEMS EUROPE GmbH is registered with the FDA (registration 3006165530) in ROSTOCK Mecklenburg-Western Pomerania, Germany. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated September 19, 2006. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3006165530
- Address
- Lange Strasse 16, ROSTOCK Mecklenburg-Western Pomerania, Germany, 18055
- Owner or operator
- IMAGE Information Systems Europe GmbH (9091611)
- Roles
- Manufacturer
- First device listed
- October 4, 2006
- Registered through
- 2027
- Brand names listed
- IQ-SYSTEM PACS
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| System, Image Processing, Radiological | LLZ | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| September 19, 2006 | K062488 | IQ-SYSTEM PACS SYSTEM | LLZ | Substantially Equivalent | Image Information Systems, Ltd. | accessdata.fda.gov |
Compare with other makers
Updated September 19, 2006. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.