Data / Medical devices / Germany / Stratec Medizintechnik GMBH
Stratec Medizintechnik GMBH: FDA-registered device maker in PFORZHEIM Baden-Wurttemberg, Germany, 1 510(k) clearance
Stratec Medizintechnik GMBH is registered with the FDA (registration 9616391) in PFORZHEIM Baden-Wurttemberg, Germany. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated October 29, 1998. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 9616391
- FEI number
- 1000646577
- Address
- Durlacher Strasse 35, PFORZHEIM Baden-Wurttemberg, Germany, 75172
- Owner or operator
- STRATEC MEDIZINTECHNIK GMBH (9039947)
- Roles
- Manufacturer
- First device listed
- March 17, 2009
- Registered through
- 2026
- Brand names listed
- XCT 2000 X-Ray Densometer, XCT 3000 X-RAY Densiometer
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Densitometer, Bone | KGI | 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 |
|---|---|---|---|---|---|---|
| October 29, 1998 | K983273 | XCT 2000 L PQCT BONE DENSITOMETER | KGI | Substantially Equivalent | Medical Systems, Inc. | accessdata.fda.gov |
Compare with other makers
Updated October 29, 1998. 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.