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 |