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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
Regulation Description Emission computed tomography system.
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 2
SIEMENS HEALTHINEERS AG
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2021 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
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

Recalls
Manufacturer Recall Class Date Posted
1 GE Healthcare, LLC II Feb-09-2022
2 GE Healthcare, LLC II Jul-12-2021
3 GE Medical Systems, LLC II Aug-02-2024
4 Siemens Medical Solutions USA, Inc I Sep-30-2025
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