The following data is part of a premarket notification filed by Siemens Medical Solutions Usa Inc. with the FDA for Biograph Mmr.
| Device ID | K103429 | 
| 510k Number | K103429 | 
| Device Name: | BIOGRAPH MMR | 
| Classification | Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance | 
| Applicant | SIEMENS MEDICAL SOLUTIONS USA INC. 810 INNOVATION DRIVE Knoxville, TN 37932 | 
| Contact | Alaine Medio | 
| Correspondent | Alaine Medio SIEMENS MEDICAL SOLUTIONS USA INC. 810 INNOVATION DRIVE Knoxville, TN 37932 | 
| Product Code | OUO | 
| CFR Regulation Number | 892.1200 [🔎] | 
| Decision | Substantially Equivalent (SESE) | 
| Type | Traditional | 
| 3rd Party Reviewed | No | 
| Combination Product | Yes | 
| Date Received | 2010-11-22 | 
| Decision Date | 2011-06-08 | 
| Summary: | summary | 
| Mark Image Registration | Serial | Company Trademark Application Date | 
|---|---|
|  BIOGRAPH MMR  85976725  4329528 Live/Registered | Siemens Medical Solutions USA, Inc. 2011-07-06 | 
|  BIOGRAPH MMR  85364765  not registered Dead/Abandoned | Siemens Medical Solutions USA, Inc. 2011-07-06 | 
|  BIOGRAPH MMR  79094871  not registered Dead/Abandoned | Siemens Healthcare GmbH 2010-12-15 |