Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance

Product Code: OUO

Radiology Diagnostic Nuclear Medicine Devices

Definition: Imager That Generates Both Both Magnetic Resonance (mr) And Positron Emission Tomography (pet) Images And Provides Registration And Fusion Of These Images. Pet And Mr Images Can Be Acquired Either Simultaneously Or Sequentially. Anatomical Mr Images Are Used For Pet Attenuation Correction.

Applicable Standards: No Standard Applicable. General Radiological Health Requirements Apply. [1000-1005]

Code of Federal Regulations: 892.1200


Radiation TypeIonizing
Radition SafetyNone
Annual ReportsNo

Products Classified as OUO

5416Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic ResonanceEmission Computed Tomography System.

Total Product Life Cycle (TPLC) Devices

5416Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic ResonanceEmission Computed Tomography System.

Pre-market Notifications for OUO

K213709SIGNA PET/MRGE Medical Systems, LLC
K200213Biograph MMR With Syngo MR E11P-AP01 System SoftwareSiemens Medical Solutions, USA, Inc.
K192672UPMR 790Shanghai United Imaging Healthcare Co., Ltd
K183014UPMR 790Shanghai United Imaging Healthcare Co., Ltd.
K172531Biograph MMR With MMR Angio Transfer OptionSiemens Medical Solutions USA, Inc.
K163619SIGNA PET/MRGE Medical Systems, LLC
K163234Biograph MMR With Syngo MR E11P System SoftwareSiemens Medical Solutions USA, Inc.
K142098SIGNA PET/MRGE MEDICAL SYSTEMS, LLC
K133226BIOGRAPH MMRSIEMENS MEDICAL SOLUTIONS USA, INC.
K103483INGENUITY TF PET/MRPHILIPS HEALTHCARE (CLEVELAND)
K103429BIOGRAPH MMRSIEMENS MEDICAL SOLUTIONS USA INC.

Global Unique Device Identification Database

04056869015446Tomographic imager combining emission computed tomography with nuclear magnetic resonance
04056869015248Tomographic imager combining emission computed tomography with nuclear magnetic resonance
04056869015156Tomographic imager combining emission computed tomography with nuclear magnetic resonance
04056869015132Tomographic imager combining emission computed tomography with nuclear magnetic resonance
04056869015125Tomographic imager combining emission computed tomography with nuclear magnetic resonance
04056869015118Tomographic imager combining emission computed tomography with nuclear magnetic resonance
04056869014777Tomographic imager combining emission computed tomography with nuclear magnetic resonance
04056869014760Tomographic imager combining emission computed tomography with nuclear magnetic resonance
04056869014753Tomographic imager combining emission computed tomography with nuclear magnetic resonance
04056869014661Tomographic imager combining emission computed tomography with nuclear magnetic resonance
04056869014524Tomographic imager combining emission computed tomography with nuclear magnetic resonance
04056869014500Tomographic imager combining emission computed tomography with nuclear magnetic resonance
04056869014456Tomographic imager combining emission computed tomography with nuclear magnetic resonance
04056869014388Tomographic imager combining emission computed tomography with nuclear magnetic resonance
04056869014302Tomographic imager combining emission computed tomography with nuclear magnetic resonance

Maude Adverse Events

SIGNA PET/MRGE MEDICAL SYSTEMS, LLC2018-11-14
SIGNA PET/MRGE MEDICAL SYSTEMS, LLC2017-04-27
CT SCANNER2017-03-18
SIGNA PETMRGE MEDICAL SYSTEMS, LLC2017-01-09
3.0T PET/MRGE MEDICAL SYSTEMS, LLC2015-07-24
CARDIOGEN-82 RUBIDIUM RB82 GENERATOR-#510BRACO DIAGNOSTICS INC.2015-06-24
CARDIOGEN-82 RUBIDIUM RB82 GENERATOR-#510BRACCO DIAGNOSTICS INC2015-06-24
CARDIOGEN-82 RUBIDIUM RB82 GENERATOR-#510BRACCO DIAGNOSTICS INC2015-06-24
INGENUITY TF PET/MRPHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.2015-04-14
BIOGRAPH MMRSIEMENS HEALTHCARE2014-08-11
INGENUITY TF PET/MRPHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.2014-03-03
INGENUITY TF PET/MRPHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.2014-01-16
INGENUITY TF PET/MRPHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.2013-12-11
INGENUITY TF PET/MRPHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.2012-02-28

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