The following data is part of a premarket notification filed by Siemens Medical Solutions Usa, Inc. with the FDA for Syngo.mr General, Syngo.mr Cardiology, Syngo.mr Neurology.
| Device ID | K163294 |
| 510k Number | K163294 |
| Device Name: | Syngo.MR General, Syngo.MR Cardiology, Syngo.MR Neurology |
| Classification | System, Image Processing, Radiological |
| Applicant | SIEMENS MEDICAL SOLUTIONS USA, INC. 40 LIBERTY BLVD MAIL CODE 65-1A Malvern, PA 19355 |
| Contact | Cordell L. Fields |
| Correspondent | Cordell L. Fields SIEMENS MEDICAL SOLUTIONS USA, INC. 65 VALLEY STREAM PKWY MAIL CODE 65-1A Malvern, PA 19355 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-11-22 |
| Decision Date | 2017-02-06 |
| Summary: | summary |