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 |