510(k) K013504 ยท KPS System, Tomography, Computed, Emission
MODIFICATION TO: ECAT LSO PET/CT SCANNER
| Applicant | Cti Pet Systems, Inc., Knoxville TN, US |
| Decision | Substantially Equivalent, Oct 31, 2001 |
| Received | Oct 22, 2001 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K013504
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 16, 2005 | CTI PET Systems Inc PET/CT Software Versions MSV 1.0 and 1.1 used in the following PET (Positron Emission Tomography) and X-Ray Computed Tomography (CT) systems:
Siemens Models: Biograph PET/CT
CTI Models: Reveal Terminated |
KPS | None listed |
| Nov 13, 2003 | Cti Pet Systems Inc Siemens Models: BIOGRAPH, BIOGRAPH LSO and CTI Models: REVEAL HD, REVEAL RT Terminated |
KPS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.