510(k) K962797 ยท KPS System, Tomography, Computed, Emission
ECAT EXACT & ECAT EXACT HR+
| Applicant | Cti Pet Systems, Inc., Knoxville TN, US |
| Decision | Substantially Equivalent, Oct 15, 1996 |
| Received | Jul 18, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K962797
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 4, 2008 | Siemens Medical Solutions USA Inc Biograph 16, Biograph PET/CT Scanner, Catalog No. 872858, Manufactured by Siemens Medical Solutions USA, Inc., 810 Innovation Drive, Knoxville, TN 37932 USA, TEL: 865-218-2534 Terminated |
KPS | None listed |
| Jan 4, 2008 | Siemens Medical Solutions USA Inc Biograph 40 - 3 Ring, Biograph PET/CT Scanner, Catalog No. 10097233, Manufactured by Siemens Medical Solutions USA, Inc., 810 Innovation Drive, Knoxville, TN 37932 USA, TEL: 865-218-2534 Terminated |
KPS | None listed |
| Jan 4, 2008 | Siemens Medical Solutions USA Inc Biograph 40 TruePoint, Biograph PET/CT Scanner, Catalog No. 10097303, Manufactured by Siemens Medical Solutions USA, Inc., 810 Innovation Drive, Knoxville, TN 37932 USA, TEL: 865-218-2534 Terminated |
KPS | None listed |
| Jan 4, 2008 | Siemens Medical Solutions USA Inc Biograph 6, Biograph PET/CT Scanner, Catalog No. 8728854, Manufactured by Siemens Medical Solutions USA, Inc., 810 Innovation Drive, Knoxville, TN 37932 USA, TEL: 865-218-2534 Terminated |
KPS | None listed |
| Jan 4, 2008 | Siemens Medical Solutions USA Inc Biograph 6, Biograph PET/CT Scanner, Catalog No. 8728573, Manufactured by Siemens Medical Solutions USA, Inc., 810 Innovation Drive, Knoxville, TN 37932 USA, TEL: 865-218-2534 Terminated |
KPS | None listed |
| Jan 4, 2008 | Siemens Medical Solutions USA Inc Biograph 64-3 Ring, Biograph PET/CT Scanner, Catalog No. 8727450, Manufactured by Siemens Medical Solutions USA, Inc., 810 Innovation Drive, Knoxville, TN 37932 USA, TEL: 865-218-2534 Terminated |
KPS | None listed |
| Jan 4, 2008 | Siemens Medical Solutions USA Inc Biograph DUO LSO, Biograph PET/CT Scanner, Catalog No. 8728813, Manufactured by Siemens Medical Solutions USA, Inc., 810 Innovation Drive, Knoxville, TN 37932 USA, TEL: 865-218-2534 Terminated |
KPS | None listed |
| Nov 29, 2007 | Siemens Medical Solutions USA Inc Siemens ECAT ACCEL, Catalog No. 3554479, PET/CT Scanner, Manufactured by Siemens Medical Solutions USA, Inc., 810 Innovation Drive, Knoxville, TN 37932 USA, TEL: 865-218-2534 Terminated |
KPS | None listed |
| Nov 29, 2007 | Siemens Medical Solutions USA Inc Siemens ECAT ART, Catalog No.. 3545584, PET/CT Scanner, Manufactured by Siemens Medical Solutions USA, Inc., 810 Innovation Drive, Knoxville, TN 37932 USA, TEL: 865-218-2534 Terminated |
KPS | None listed |
| Nov 29, 2007 | Siemens Medical Solutions USA Inc Siemens ECAT EXACT 47, Catalog No. 1788772, PET/CT Scanner, Manufactured by Siemens Medical Solutions USA, Inc., 810 Innovation Drive, Knoxville, TN 37932 USA, TEL: 865-218-2534 Terminated |
KPS | None listed |
| Nov 29, 2007 | Siemens Medical Solutions USA Inc Siemens ECAT EXACT HR 47, Catalog No. 2956261, PET/CT Scanner, Manufactured by Siemens Medical Solutions USA, Inc., 810 Innovation Drive, Knoxville, TN 37932 USA, TEL: 865-218-2534 Terminated |
KPS | None listed |
| Nov 29, 2007 | Siemens Medical Solutions USA Inc Siemens ECAT EXACT HR+, Catalog No. 3548083, PET/CT Scanner, Manufactured by Siemens Medical Solutions USA, Inc., 810 Innovation Drive, Knoxville, TN 37932 USA, TEL: 865-218-2534 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 |
| 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.