510(k) K003241 ยท KPS System, Tomography, Computed, Emission
ECAT PET SCANNER
| Applicant | Cti Pet Systems, Inc., Knoxville TN, US |
| Decision | Substantially Equivalent, Dec 13, 2000 |
| Received | Oct 17, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K003241
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 4, 2006 | Siemens Medical Solutions USA Inc ECAT Emerge PET Scanners (distributed by Siemens Medical Solutions USA, Inc.), ECAT ART PET Scanners (distributed by Siemens Medical Solutions USA, Inc.) and Sceptre PET Scanners (distributed by Hitac Terminated |
KPS | None listed |
| May 11, 2005 | CTI PET Systems Inc ECAT PET Scanners (mobile systems), distributed by Siemens Medical Solutions
ECAT PET Scanners (mobile systems), and Reveal XL (mobile systems), distributed by CTI Molecular Imagining, Inc.
Sceptre an Terminated |
KPS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.