27 results
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10ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: Class Ii
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GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA Voyager and SIGNA Voyager Premier Edition system, nuclear magnetic resonance imaging system.
FDA Enforcement
Class II
·Ongoing·GE Healthcare, LLC·February 16, 2022
SIGNA Voyager, Nuclear Magnetic Resonance Imaging System
FDA Enforcement
Class II
·Ongoing·GE Healthcare, LLC·July 21, 2021
SIGNA Voyager nuclear magnetic resonance imaging system
FDA Enforcement
Class II
·Terminated·GE Healthcare, LLC·October 27, 2021
GE Signa Voyager, Nuclear Magnetic Resonance Imaging System
FDA Enforcement
Class II
·Ongoing·GE Medical Systems, LLC·August 20, 2025
GE SIGNA Voyager AIR (China Only), Nuclear Magnetic Resonance Imaging System
FDA Enforcement
Class II
·Ongoing·GE Medical Systems, LLC·August 20, 2025
SIGNA Voyager, with affected software versions: PX26.0 to PX26.6, VX28.0, VX29.1, VX29.2, MR30.0, MR30.1; Nuclear Magnetic Resonance Imaging System
FDA Enforcement
Class II
·Ongoing·GE Medical Systems, LLC·August 14, 2024
GE SIGNA Premier Elite (China Only), Nuclear Magnetic Resonance Imaging System
FDA Enforcement
Class II
·Ongoing·GE Medical Systems, LLC·August 20, 2025
GE SIGNA Hero Elite (China Only), Nuclear Magnetic Resonance Imaging System
FDA Enforcement
Class II
·Ongoing·GE Medical Systems, LLC·August 20, 2025
GE SIGNA Premier MAX (China Only), Nuclear Magnetic Resonance Imaging System
FDA Enforcement
Class II
·Ongoing·GE Medical Systems, LLC·August 20, 2025
GE SIGNA Hero XT (China Only), Nuclear Magnetic Resonance Imaging System
FDA Enforcement
Class II
·Ongoing·GE Medical Systems, LLC·August 20, 2025
GE SIGNA UHP, Nuclear Magnetic Resonance Imaging System
FDA Enforcement
Class II
·Ongoing·GE Medical Systems, LLC·August 20, 2025
GE SIGNA Hero MAX (China Only), Nuclear Magnetic Resonance Imaging System
FDA Enforcement
Class II
·Ongoing·GE Medical Systems, LLC·August 20, 2025
GE Discovery MR750w 3.0T, Nuclear Magnetic Resonance Imaging System
FDA Enforcement
Class II
·Ongoing·GE Medical Systems, LLC·August 20, 2025
GE SIGNA Hero, Nuclear Magnetic Resonance Imaging System
FDA Enforcement
Class II
·Ongoing·GE Medical Systems, LLC·August 20, 2025
GE SIGNA PET/MR AIR (China Only), Nuclear Magnetic Resonance Imaging System
FDA Enforcement
Class II
·Ongoing·GE Medical Systems, LLC·August 20, 2025
GE SIGNA PET/MR AIR Plus (China Only), Nuclear Magnetic Resonance Imaging System
FDA Enforcement
Class II
·Ongoing·GE Medical Systems, LLC·August 20, 2025
GE SIGNA Premier XT (China Only), Nuclear Magnetic Resonance Imaging System
FDA Enforcement
Class II
·Ongoing·GE Medical Systems, LLC·August 20, 2025
GE Discovery MR450 1.5T, Nuclear Magnetic Resonance Imaging System
FDA Enforcement
Class II
·Ongoing·GE Medical Systems, LLC·August 20, 2025
GE Signa Artist, Nuclear Magnetic Resonance Imaging System
FDA Enforcement
Class II
·Ongoing·GE Medical Systems, LLC·August 20, 2025
GE SIGNA Architect AIR (China Only), Nuclear Magnetic Resonance Imaging System
FDA Enforcement
Class II
·Ongoing·GE Medical Systems, LLC·August 20, 2025