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GE Healthcare Imaging

    https://www.gehealthcare.com/products/imaging

    GE Medical Systems Israel - Functional Imaging

      https://medicaldevices.icij.org/manufacturers/danish-medicines-agency-ge-medical-systems-israel-functional-imaging
      GE Medical Systems Israel - Functional Imaging Manufacturer Parent Company (2017) General Electric Company Source DMA 1 Event Field Safety Notices about infinia, vg, vg …

    International Medical Devices Database

      https://medicaldevices.icij.org/manufacturers/department-of-health-ge-medical-systems-israel
      GE Medical Systems Israel Manufacturer Parent Company (2017) General Electric Company Source DH 1 Event Safety Alert for Discovery NM/CT 670 System One device …

    GE HealthCare issues Class I recall of hospital imaging …

      https://www.bizjournals.com/milwaukee/news/2023/02/17/ge-healthcare-recall.html
      1 day ago · Feb 17, 2023. GE HealthCare issued a recall for one of its devices over concerns that it could cause serious injury or death to patients. The Food and Drug …

    GE Healthcare QSJM GE Medical Systems Israel, …

      https://www.accessdata.fda.gov/cdrh_docs/pdf17/K173816.pdf
      Submitter: GE Medical Systems Israel, Functional Imaging (GE Healthcare) 4 Hayozma Street Tirat Hacarmel, 30200, Israel Primary Contact: George Mashour Regulatory …

    Medical Device Recalls

      https://www.accessdata.fda.gov/SCRIPTs/cdrh/cfdocs/cfres/res.cfm?start_search=1&event_id=91456
      GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING Z-1057-2023 - GE Nuclear Medicine 600/800 series systems, specifically: a) 870 CZT O540+ Gantry 7.25mm, b) …

    Class 1 Device Recall GE

      https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=197812
      GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING 4, Hayozma St Tirat Carmel Israel For Additional Information Contact: GE HealthCare Service 800 …

    Class 1 Device Recall GE - accessdata.fda.gov

      https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=197814
      Class 1 Device Recall GE Class 1 Device Recall GE FDA Home Medical Devices Databases 510 (k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | …

    MAUDE Adverse Event Report: GE MEDICAL …

      https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4092453&pc=KPS
      GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING: tirat hacarmel : IS Manufacturer Contact: paul corrigan 3000 n. grandview blvd: waukesha, WI 53188 …

    5507043-199 r4 DaTQUANT eIFU and User …

      https://www.gehealthcare.com/-/media/global/products/files/nuclear-imaging-agents/datquant/datquant-user-manualv2-nonadpromo.pdf?rev=-1
      detection of loss of functional dopaminergic neuron terminals in the striatum, which is correlated with Parkinson disease. Electronic Information For Use This software is …



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