Recognized a 510(k)/PMA number — showing its clearance record and devices.
Clearance record K141971
BIOGRAPH TRUE PET/CT FAMILY SOFTWARE · Siemens Medical Solutions USA, Inc. · decided 2014-09-12 (SESE)
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| Biograph 16 TruePoint - 3R | 10249555 | SIEMENS MEDICAL SOLUTIONS USA, INC. | KPS | 04056869001722 |
| TOP LEVEL BIOGRAPH 6-4R W/0 CT | 10245859 | SIEMENS MEDICAL SOLUTIONS USA, INC. | KPS | 04056869001715 |
| TOP LEVEL BIOGRAPH 6-3R W/0 CT | 10245858 | SIEMENS MEDICAL SOLUTIONS USA, INC. | KPS | 04056869001708 |
| Biograph Advanced Workflow (B64/40) | 10097284 | SIEMENS MEDICAL SOLUTIONS USA, INC. | KPS | 04056869001838 |
| Biograph 16 TruePoint TrueV - 4R | 10249556 | SIEMENS MEDICAL SOLUTIONS USA, INC. | KPS | 04056869001739 |
| TOP LEVEL BIOGRAPH 64-3R W/0 CT | 10245854 | SIEMENS MEDICAL SOLUTIONS USA, INC. | KPS | 04056869001661 |
| TOP LEVEL BIOGRAPH 64-4R W/O CT | 10245856 | SIEMENS MEDICAL SOLUTIONS USA, INC. | KPS | 04056869001678 |
| BIOGRAPH Advanced Workflow (B16) | 10249725 | SIEMENS MEDICAL SOLUTIONS USA, INC. | KPS | 04056869001821 |
| Biograph Advanced Workflow (B6) | 10097291 | SIEMENS MEDICAL SOLUTIONS USA, INC. | KPS | 04056869001814 |
| TOP LEVEL BIOGRAPH 40-4R W/0 CT | 10245857 | SIEMENS MEDICAL SOLUTIONS USA, INC. | KPS | 04056869001692 |
| TOP LEVEL BIOGRAPH 40-3R W/0 CT | 10245855 | SIEMENS MEDICAL SOLUTIONS USA, INC. | KPS | 04056869001685 |