The following data is part of a premarket notification filed by Siemens Ag, Medical Solutions with the FDA for Syngo Volume Perfusion-ct Body.
| Device ID | K092013 |
| 510k Number | K092013 |
| Device Name: | SYNGO VOLUME PERFUSION-CT BODY |
| Classification | System, X-ray, Tomography, Computed |
| Applicant | SIEMENS AG, MEDICAL SOLUTIONS SIEMENSSTRASSE 1 Forchheim, DE 91301 |
| Correspondent | Stefam Preiss TUV SUD AMERICA INC. 1775 OLD HIGHWAY 8 NW New Brighton, MN 55112 -1891 |
| Product Code | JAK |
| CFR Regulation Number | 892.1750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2009-07-06 |
| Decision Date | 2009-07-17 |
| Summary: | summary |