The following data is part of a premarket notification filed by Siemens Medical Solutions Usa, Inc. with the FDA for Syngo Dynamics, Version 9.0.
| Device ID | K102150 |
| 510k Number | K102150 |
| Device Name: | SYNGO DYNAMICS, VERSION 9.0 |
| Classification | System, Image Processing, Radiological |
| Applicant | SIEMENS MEDICAL SOLUTIONS USA, INC. 400 W. MORGAN ROAD Ann Arbor, MI 48108 |
| Contact | Yuri Ikeda |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2010-07-29 |
| Decision Date | 2010-10-05 |
| Summary: | summary |