Data / Medical devices / United States / Spintech, Inc.
Spintech, Inc.: FDA-registered device maker in Bingham Farms, MI, United States, 1 510(k) clearance
Spintech, Inc. is registered with the FDA (registration 3020162557) in Bingham Farms, MI, United States. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated October 28, 2022. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3020162557
- Address
- 30200 Telegraph Road SUITE 140, Bingham Farms, MI, United States, 48025
- Owner or operator
- SpinTech, Inc. (10082616)
- Roles
- Manufacturer
- First device listed
- November 21, 2022
- Registered through
- 2027
- Brand names listed
- STAGE
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| System, Image Processing, Radiological | LLZ | 2 | Manufacturer | accessdata.fda.gov |
| System, Nuclear Magnetic Resonance Imaging | LNH | 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 28, 2022 | K223079 | Stage | LNH | Substantially Equivalent | Spintech, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of System, Image Processing, Radiological
- All makers of System, Nuclear Magnetic Resonance Imaging
Updated October 28, 2022. 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.