The following data is part of a premarket notification filed by Siemens Medical Solutions Usa, Inc. with the FDA for Syngo.mr Neurology, Syngo.mmr General.
| Device ID | K140897 |
| 510k Number | K140897 |
| Device Name: | SYNGO.MR NEUROLOGY, SYNGO.MMR GENERAL |
| Classification | System, Image Processing, Radiological |
| Applicant | SIEMENS MEDICAL SOLUTIONS USA, INC. 51 VALLEY STREAM PARKWAY Malvern, PA 19355 |
| Contact | Cordell L Fields, Esq. |
| Correspondent | Cordell L Fields, Esq. SIEMENS MEDICAL SOLUTIONS USA, INC. 51 VALLEY STREAM PARKWAY 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 | 2014-04-07 |
| Decision Date | 2014-07-18 |
| Summary: | summary |