The following data is part of a premarket notification filed by Siemens Medical Solutions, Usa, Inc. with the FDA for Biograph Mmr With Syngo Mr E11p-ap01 System Software.
| Device ID | K200213 |
| 510k Number | K200213 |
| Device Name: | Biograph MMR With Syngo MR E11P-AP01 System Software |
| Classification | Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance |
| Applicant | Siemens Medical Solutions, USA, Inc. 40 Liberty Boulevard Mailcode 65-1A Malvern, PA 19355 |
| Contact | Cordell L. Fields |
| Correspondent | Cordell L. Fields Siemens Medical Solutions, USA, Inc. 40 Liberty Boulevard Mailcode 65-1A Malvern, PA 19355 |
| Product Code | OUO |
| Subsequent Product Code | KPS |
| Subsequent Product Code | LNH |
| Subsequent Product Code | LNI |
| CFR Regulation Number | 892.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-01-28 |
| Decision Date | 2020-05-11 |