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 |