Data / Medical devices / Germany / Diagnostic Green GMBH
Diagnostic Green GMBH: FDA-registered device maker in Munich Bavaria, Germany, 1 510(k) clearance
Diagnostic Green GMBH is registered with the FDA (registration 3042243691) in Munich Bavaria, Germany. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated September 22, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3042243691
- Address
- Feldkirchener Str. 7c, 85551 Kirchheim bei Munchen, Munich Bavaria, Germany, 85551
- Owner or operator
- Diagnostic Green GmbH (10094429)
- Roles
- Specification developer
- First device listed
- November 28, 2025
- Registered through
- 2026
- Brand names listed
- IC Flow Imaging System 2
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| System, X-Ray, Angiographic | IZI | 2 | Specification developer | 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 22, 2025 | K243645 | IC-Flow Imaging System 2.0 | IZI | Substantially Equivalent | Diagnostic Green GmbH | accessdata.fda.gov |
Compare with other makers
Updated September 22, 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.