BIOGRAPH MMR

Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance

SIEMENS MEDICAL SOLUTIONS USA, INC.

The following data is part of a premarket notification filed by Siemens Medical Solutions Usa, Inc. with the FDA for Biograph Mmr.

Pre-market Notification Details

Device IDK133226
510k NumberK133226
Device Name:BIOGRAPH MMR
ClassificationTomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance
Applicant SIEMENS MEDICAL SOLUTIONS USA, INC. 51 VALLEY STREAM PKWY. Malvern,  PA  19355 -1406
ContactNadia Sookdeo
CorrespondentNadia Sookdeo
SIEMENS MEDICAL SOLUTIONS USA, INC. 51 VALLEY STREAM PKWY. Malvern,  PA  19355 -1406
Product CodeOUO  
CFR Regulation Number892.1200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-10-21
Decision Date2013-11-12
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
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

Trademark Results [BIOGRAPH MMR]

Mark Image

Registration | Serial
Company
Trademark
Application Date
BIOGRAPH MMR
BIOGRAPH MMR
85976725 4329528 Live/Registered
Siemens Medical Solutions USA, Inc.
2011-07-06
BIOGRAPH MMR
BIOGRAPH MMR
85364765 not registered Dead/Abandoned
Siemens Medical Solutions USA, Inc.
2011-07-06
BIOGRAPH MMR
BIOGRAPH MMR
79094871 not registered Dead/Abandoned
Siemens Healthcare GmbH
2010-12-15

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