Data / Medical devices / Germany / Thinksono GMBH
Thinksono GMBH: FDA-registered device maker in Potsdam Brandenburg, Germany, 1 510(k) clearance
Thinksono GMBH is registered with the FDA (registration 3018394847) in Potsdam Brandenburg, Germany. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated July 15, 2026. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3018394847
- Address
- Hpi Seed Fund Gmbh August-Bebel-Str. 88, Potsdam Brandenburg, Germany, 14482
- Owner or operator
- ThinkSono GmbH (10081298)
- Roles
- Manufacturer
- First device listed
- August 4, 2026
- Registered through
- 2026
- Brand names listed
- ThinkSono Guidance
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Image Acquisition And/Or Optimization Guided By Artificial Intelligence | QJU | 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 |
|---|---|---|---|---|---|---|
| July 15, 2026 | K260338 | ThinkSono Guidance | QJU | Substantially Equivalent | ThinkSono GmbH | accessdata.fda.gov |
Compare with other makers
Updated July 15, 2026. 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.