Data / Medical devices / Germany / Image Instruments GMBH
Image Instruments GMBH: FDA-registered device maker in Chemnitz Saxony, Germany, 1 510(k) clearance
Image Instruments GMBH is registered with the FDA (registration 3026391019) in Chemnitz Saxony, Germany. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated January 4, 2023. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3026391019
- Address
- Niederwaldstr. 3, Chemnitz Saxony, Germany, 09123
- Owner or operator
- Image Instruments GmbH (10087224)
- Roles
- Manufacturer
- First device listed
- January 31, 2023
- Registered through
- 2027
- Brand names listed
- OnyxCeph
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Orthodontic Software | PNN | 2 | Manufacturer | accessdata.fda.gov |
| 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 |
|---|---|---|---|---|---|---|
| January 4, 2023 | K213263 | OnyxCeph | LLZ | Substantially Equivalent | Image Instruments GmbH | accessdata.fda.gov |
Compare with other makers
Updated January 4, 2023. 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.