62 results
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20ms
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Sources: EU EUDAMED, US FDA
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Country: Israel
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SMV DSI, System, Tomography, Computed, Emission
FDA Enforcement
Class II
·Ongoing·GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING·January 21, 2026
MAXXUS, System, Tomography, Computed, Emission
FDA Enforcement
Class II
·Ongoing·GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING·January 21, 2026
SMV BodyTrack, System, Tomography, Computed, Emission
FDA Enforcement
Class II
·Ongoing·GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING·January 21, 2026
SMV DSX New Line, System, Tomography, Computed, Emission
FDA Enforcement
Class II
·Ongoing·GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING·January 21, 2026
Snapshot Tracker Kit, Mas2659-01, KIT0898, Rx Only, Non Sterile, UDI: 07290109181868
FDA Enforcement
Class II
·Terminated·Mazor Robotics Ltd·January 1, 2020
Maxicam; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging
FDA Enforcement
Class II
·Ongoing·GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING·October 29, 2025
Millenium MPR; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging
FDA Enforcement
Class II
·Ongoing·GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING·October 29, 2025
Elscint Model 4XX; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging
FDA Enforcement
Class II
·Ongoing·GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING·October 29, 2025
Elscint Helix; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging
FDA Enforcement
Class II
·Ongoing·GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING·October 29, 2025
Millenium MPS; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging
FDA Enforcement
Class II
·Ongoing·GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING·October 29, 2025
Millenium Myosight; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging
FDA Enforcement
Class II
·Ongoing·GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING·October 29, 2025
Elscint SPX6; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging
FDA Enforcement
Class II
·Ongoing·GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING·October 29, 2025
Elscint SPX4; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging
FDA Enforcement
Class II
·Ongoing·GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING·October 29, 2025
Millenium MG/MC; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging
FDA Enforcement
Class II
·Ongoing·GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING·October 29, 2025
Elscint Cardial; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging
FDA Enforcement
Class II
·Ongoing·GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING·October 29, 2025
Elscint Varicam; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging
FDA Enforcement
Class II
·Ongoing·GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING·October 29, 2025
Optima NX; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging
FDA Enforcement
Class II
·Ongoing·GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING·October 29, 2025
Starcam/Camstar; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging
FDA Enforcement
Class II
·Ongoing·GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING·October 29, 2025
Sopha Medical Vision (SMV) DSXi/DST-XLi,/ DST-XL/ DSTi; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging
FDA Enforcement
Class II
·Ongoing·GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING·October 29, 2025
McKesson Cardiology Hemo, Release SW version 13.0. Used for physiological monitoring, image and data processing. McKesson Cardiology Hemo is intended for complete physiological/hemodynamic monitoring, clinical data acquisition, medical image and data processing, and analytical assessment. McKesson Cardiology Hemo is also intended for patient/procedural data management, such as documentation, logging, reporting, trending, storing, reviewing, carrying out clinical calculations and exporting various representations of the acquired data.
FDA Enforcement
Class II
·Terminated·McKesson Israel Ltd.·September 12, 2018