510(k) K022565 ยท JAA System, X-Ray, Fluoroscopic, Image-Intensified
TELSTAR BIPLANE DIGITAL IMAGING SYSTEM [TIS] MODEL 030-000915
| Applicant | Stereotaxis, Inc., Saint Louis MO, US |
| Decision | Substantially Equivalent, Oct 8, 2002 |
| Received | Aug 2, 2002 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K022565
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.