The following data is part of a premarket notification filed by Siemens Medical Solutions Usa, Inc. with the FDA for Syngo.mr Spectro Engine, Syngo.mr Spectro Svs, Syngo.mr Spectro Csi, Syngo.mr Spectro Extension.
| Device ID | K120315 |
| 510k Number | K120315 |
| Device Name: | SYNGO.MR SPECTRO ENGINE, SYNGO.MR SPECTRO SVS, SYNGO.MR SPECTRO CSI, SYNGO.MR SPECTRO EXTENSION |
| Classification | System, Image Processing, Radiological |
| Applicant | SIEMENS MEDICAL SOLUTIONS USA, INC. 51 VALLEY STREAM PARKWAY Malvern, PA 19355 |
| Contact | Nadia Sookdeo |
| Correspondent | Nadia Sookdeo 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 | 2012-02-01 |
| Decision Date | 2012-04-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04056869043197 | K120315 | 000 |
| 04056869012841 | K120315 | 000 |
| 04056869012766 | K120315 | 000 |