The following data is part of a premarket notification filed by Siemens Medical Solutions, Inc. with the FDA for Software Syngo Mr D13a For The Magnetom Systems Aera/skyra/avanto/verio.
| Device ID | K121434 |
| 510k Number | K121434 |
| Device Name: | SOFTWARE SYNGO MR D13A FOR THE MAGNETOM SYSTEMS AERA/SKYRA/AVANTO/VERIO |
| Classification | System, Nuclear Magnetic Resonance Imaging |
| Applicant | SIEMENS MEDICAL SOLUTIONS, INC. 51 VALLEY STREAM PARKWAY MAIL CODE D02 Malvern, PA 19355 |
| Contact | Michelle L Byrne |
| Correspondent | Michelle L Byrne SIEMENS MEDICAL SOLUTIONS, INC. 51 VALLEY STREAM PARKWAY MAIL CODE D02 Malvern, PA 19355 |
| Product Code | LNH |
| Subsequent Product Code | LNI |
| Subsequent Product Code | MOS |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-05-14 |
| Decision Date | 2012-11-05 |
| Summary: | summary |