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 |