Data / Medical devices / Germany / Metamorphosis GMBH
Metamorphosis GMBH: FDA-registered device maker in Paderborn North Rhine-Westphalia, Germany, 1 510(k) clearance
Metamorphosis GMBH is registered with the FDA (registration 3042243683) in Paderborn North Rhine-Westphalia, Germany. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated October 7, 2025. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3042243683
- Address
- Technologiepark 9, Paderborn North Rhine-Westphalia, Germany, 33100
- Owner or operator
- metamorphosis GmbH (10094288)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- November 21, 2025
- Registered through
- 2027
- Brand names listed
- AIAS Cephalon, VELYS Trauma
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Automated Radiological Image Processing Software | QIH | 2 | Complaint file establishment, 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 |
|---|---|---|---|---|---|---|
| October 7, 2025 | K252214 | AIAS Cephalon | QIH | Substantially Equivalent | Metamorphosis GmbH | accessdata.fda.gov |
Compare with other makers
Updated October 7, 2025. 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.