The following data is part of a premarket notification filed by Siemens Medical Solutions Usa, Inc. with the FDA for Magnetom Artis Combi Suite For The Magnetom Aera/skyra/skyra With Timtx Trueshape.
| Device ID | K140253 |
| 510k Number | K140253 |
| Device Name: | MAGNETOM ARTIS COMBI SUITE FOR THE MAGNETOM AERA/SKYRA/SKYRA WITH TIMTX TRUESHAPE |
| Classification | System, Nuclear Magnetic Resonance Imaging |
| Applicant | SIEMENS MEDICAL SOLUTIONS USA, INC. 51 VALLEY STREAM PARKWAY, MAILCODE D02 Malvern, PA 19355 |
| Contact | Cordell Fields |
| Correspondent | Cordell Fields SIEMENS MEDICAL SOLUTIONS USA, INC. 51 VALLEY STREAM PARKWAY, MAILCODE D02 Malvern, PA 19355 |
| Product Code | LNH |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-01-31 |
| Decision Date | 2014-03-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04056869006710 | K140253 | 000 |
| 04056869006703 | K140253 | 000 |
| 04056869006697 | K140253 | 000 |