The following data is part of a premarket notification filed by Siemens Medical Solutions Usa, Inc. with the FDA for Syngo.mr Neurology, Syngo.mr Oncology.
| Device ID | K151353 |
| 510k Number | K151353 |
| Device Name: | Syngo.MR Neurology, Syngo.MR Oncology |
| Classification | System, Image Processing, Radiological |
| Applicant | SIEMENS MEDICAL SOLUTIONS USA, INC. 51 VALLEY STREAM PARKWAY Mavern, PA 19355 |
| Contact | Cordell L. Fields |
| Correspondent | Cordell L. Fields SIEMENS MEDICAL SOLUTIONS USA, INC. 51 VALLEY STREAM PARKWAY Mavern, 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 | 2015-05-20 |
| Decision Date | 2015-08-07 |
| Summary: | summary |