The following data is part of a premarket notification filed by Siemens Medical Solutions Usa, Inc. with the FDA for Biograph 16 True Point Systems.
| Device ID | K083852 |
| 510k Number | K083852 |
| Device Name: | BIOGRAPH 16 TRUE POINT SYSTEMS |
| Classification | System, Tomography, Computed, Emission |
| Applicant | SIEMENS MEDICAL SOLUTIONS USA, INC. 810 INNOVATION DRIVE Knoxville, TN 37932 |
| Contact | Alaine Medio |
| Correspondent | Alaine Medio SIEMENS MEDICAL SOLUTIONS USA, INC. 810 INNOVATION DRIVE Knoxville, TN 37932 |
| Product Code | KPS |
| CFR Regulation Number | 892.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-12-24 |
| Decision Date | 2009-03-23 |
| Summary: | summary |