510(k) K850397 ยท IYX Camera, Scintillation (Gamma)
ORBITOR II COUNTER BALANCE CAMERA
| Applicant | Siemens Gammasonics, Inc., Des Plaines IL, US |
| Decision | Substantially Equivalent, Mar 26, 1985 |
| Received | Feb 1, 1985 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K850397
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 6, 2003 | Siemens Medical Solutions USA, Inc. Integrated Orbiter Single Detector General Purpose Gamma Camera System; Siemens Medical Systems, Inc., Nuclear Medicine Group, 2501 North Barrington Road, Hoffman Estates, IL 60195-5203 Terminated |
IYX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.