510(k) K092365 ยท JAK System, X-Ray, Tomography, Computed
INREACH SYSTEM, MODEL AAS00161-02
| Applicant | Superdimension, Ltd., Plymouth MN, US |
| Decision | Substantially Equivalent, Sep 4, 2009 |
| Received | Aug 5, 2009 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K092365
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.