The following data is part of a premarket notification filed by Siemens Ag, Medical Solutions with the FDA for Syngo.x.
| Device ID | K092519 |
| 510k Number | K092519 |
| Device Name: | SYNGO.X |
| Classification | System, Image Processing, Radiological |
| Applicant | SIEMENS AG, MEDICAL SOLUTIONS HENKESTRASSE 127 Erlangen, DE 91052 |
| Contact | Sven Knoke |
| Correspondent | Stefan Preiss TUV SUD AMERICA INC. 1775 OLD HIGHWAY 8 NW New Brighton, MN 55112 -1891 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2009-08-18 |
| Decision Date | 2009-08-27 |
| Summary: | summary |