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U.S. Department of Health and Human Services

Medical Device Recalls
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1 to 7 of 7 Results
510(K) Number: K163619
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GE SIGNA PET/MR, Tomographic Imager Combining Emission Computed Tomography with Nuclear Magnetic Res... 2 08/13/2025 GE Medical Systems, LLC
Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance: 1) SIGNA... 2 11/22/2024 GE Medical Systems, LLC
SIGNA PET/MR, with affected software versions: MP24.0, MP26.0, MP26.1, MR30.0, MR30.1; Tomographic ... 2 08/02/2024 GE Medical Systems, LLC
GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA PET/MR System, tomograp... 2 02/09/2022 GE Healthcare, LLC
SIGNA PET/MR, Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resona... 2 07/12/2021 GE Healthcare, LLC
Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance - Product ... 2 10/20/2020 GE Healthcare, LLC
Signa PET/MR (K163619, K142098) Product Usage: The SIGNA PET/MR system combines magnetic resonan... 2 08/02/2017 GE Medical Systems, LLC
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