510(k) K913637 ยท KPS System, Tomography, Computed, Emission
ECAT SCANNER (MODEL 921)
| Applicant | Cti Pet Systems, Inc., Knoxville TN, US |
| Decision | Substantially Equivalent, Nov 27, 1991 |
| Received | Aug 15, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K913637
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 21, 2003 | Cti Pet Systems Inc ECAT Software Versions V7.1.1b, V7.2, V7.2.1, and V7.2.2 used in the following PET (Positron Emission Tomography) systems:
Siemens Models: ECAT EXACT, ECAT EXACT HR, ECAT EXACT HR+, ECAT ART, ECA Terminated |
KPS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.