The following data is part of a premarket notification filed by Siemens Medical Solutions Usa, Inc. with the FDA for Biograph True Pet/ct Family Software.
| Device ID | K141971 |
| 510k Number | K141971 |
| Device Name: | BIOGRAPH TRUE PET/CT FAMILY SOFTWARE |
| Classification | System, Tomography, Computed, Emission |
| Applicant | SIEMENS MEDICAL SOLUTIONS USA, INC. 810 INNOVATION DR. Knoxville, TN 37932 |
| Contact | Alaine Medio |
| Correspondent | Alaine Medio SIEMENS MEDICAL SOLUTIONS USA, INC. 810 INNOVATION DR. Knoxville, TN 37932 |
| Product Code | KPS |
| CFR Regulation Number | 892.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-07-21 |
| Decision Date | 2014-09-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04056869001838 | K141971 | 000 |
| 04056869001678 | K141971 | 000 |
| 04056869001685 | K141971 | 000 |
| 04056869001692 | K141971 | 000 |
| 04056869001708 | K141971 | 000 |
| 04056869001715 | K141971 | 000 |
| 04056869001722 | K141971 | 000 |
| 04056869001739 | K141971 | 000 |
| 04056869001814 | K141971 | 000 |
| 04056869001821 | K141971 | 000 |
| 04056869001661 | K141971 | 000 |