The following data is part of a premarket notification filed by Siemens Medical Solutions Usa, Inc. with the FDA for Biograph Mmr.
| Device ID | K133226 |
| 510k Number | K133226 |
| Device Name: | BIOGRAPH MMR |
| Classification | Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance |
| Applicant | SIEMENS MEDICAL SOLUTIONS USA, INC. 51 VALLEY STREAM PKWY. Malvern, PA 19355 -1406 |
| Contact | Nadia Sookdeo |
| Correspondent | Nadia Sookdeo SIEMENS MEDICAL SOLUTIONS USA, INC. 51 VALLEY STREAM PKWY. Malvern, PA 19355 -1406 |
| Product Code | OUO |
| CFR Regulation Number | 892.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-10-21 |
| Decision Date | 2013-11-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04056869015446 | K133226 | 000 |
| 04056869015156 | K133226 | 000 |
| 04056869015132 | K133226 | 000 |
| 04056869015125 | K133226 | 000 |
| 04056869015118 | K133226 | 000 |
| 04056869014777 | K133226 | 000 |
| 04056869014760 | K133226 | 000 |
| 04056869014753 | K133226 | 000 |
| 04056869006741 | K133226 | 000 |
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 |