The following data is part of a premarket notification filed by Siemens Medical Solutions, Usa, Inc with the FDA for Symbia 6.5.
| Device ID | K162337 |
| 510k Number | K162337 |
| Device Name: | Symbia 6.5 |
| Classification | System, Tomography, Computed, Emission |
| Applicant | SIEMENS MEDICAL SOLUTIONS, USA, INC 2501 N. BARRINGTON ROAD Hoffman Estates, IL 60192 |
| Contact | Cynthia Busch |
| Correspondent | Cynthia Busch SIEMENS MEDICAL SOLUTIONS, USA, INC 2501 N. BARRINGTON ROAD Hoffman Estates, IL 60192 -2061 |
| Product Code | KPS |
| CFR Regulation Number | 892.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-08-22 |
| Decision Date | 2016-09-08 |
| Summary: | summary |