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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device tomographic imager combining emission computed tomography with nuclear magnetic resonance
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.
Product CodeOUO
Regulation Number 892.1200
Device Class 2


Premarket Reviews
ManufacturerDecision
GE MEDICAL SYSTEMS, LLC
  SUBSTANTIALLY EQUIVALENT 1
SHANGHAI UNITED IMAGING HEALTHCARE CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
SHANGHAI UNITED IMAGING HEALTHCARE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
SIEMENS MEDICAL SOLUTIONS, USA, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 1 1
2021 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Unintended System Motion 1 1
Use of Device Problem 1 1
Adverse Event Without Identified Device or Use Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Laceration(s) 1 1
No Consequences Or Impact To Patient 1 1

Recalls
Manufacturer Recall Class Date Posted
1 GE Healthcare, LLC II Feb-09-2022
2 GE Healthcare, LLC II Jul-12-2021
3 GE Healthcare, LLC II Oct-20-2020
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