55 results
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8ms
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Sources: EU EUDAMED, US FDA
GE Healthcare, Discovery XR656P/N 5374989/5397837 is intended to generate digital radiographic images of the skull, spinal column, chest, abdomen, extremities and other body parts in patients of all ages.
FDA Enforcement
Class II
·Terminated·GE Healthcare, LLC·August 27, 2014
Innova IGS 630/520/530/540 Interventional Fluoroscopic X-ray Systems
FDA Enforcement
Class II
·Terminated·GE Medical Systems, SCS·July 18, 2018
GE Healthcare, Revolution CT Scanners. Revolution CT- The system is intended for head, whole body, cardiac and vascular X-ray Computed Tomography applications. The system is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission projection data from the same axial plane taken at different angles.
FDA Enforcement
Class II
·Terminated·GE Medical Systems, LLC·December 16, 2015
GE Healthcare SIGNA Creator, SIGNA Explorer. Diagnostic Imaging Device.
FDA Enforcement
Class II
·Terminated·GE Healthcare, LLC·September 14, 2016
NM/CT 850 Product Usage: The GE NM/CT 850 system is intended for general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body. It includes a general purpose Nuclear Medicine system using a variety of scanning modes supported by various acquisition types, and a Computed Tomography component which is intended specifically for enabling attenuation correction and anatomical localization of SPECT images.
FDA Enforcement
Class II
·Terminated·GE Healthcare, LLC·May 8, 2019
Optima NM/CT 640 Product Usage: The GE Optima NM/CT 640 system is intended for General Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body. It includes a general purpose Nuclear Medicine (NM) system using a variety of scanning modes supported by various acquisition types, and a CT component which is intended specifically for enabling attenuation correction and anatomical localization on SPECT studies.
FDA Enforcement
Class II
·Terminated·GE Healthcare, LLC·May 8, 2019
NM/CT 870 DR Product Usage: The GE Discovery NM/CT 670 system is a medical tool intended for use by appropriately trained health professionals to aid in detecting, localizing, diagnosing of diseases and organ function for the evaluation of diseases, trauma, abnormalities, and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer. The system output can also be used by the physician for staging and restaging of tumors, planning, guiding, and monitoring therapy. The GE Discovery NM/CT 670 system, combining Nuclear Medicine (NM) and Computed Tomography (CT) systems, is intended to produce
FDA Enforcement
Class II
·Terminated·GE Healthcare, LLC·May 8, 2019
Discovery NM 630 Product Usage: The Discovery NM 630 is an all-purpose dual detector nuclear imaging system intended for general nuclear medicine imaging procedures for detection of radioisotope tracer uptake in the patient body, using a variety of scanning modes supported by various acquisition types and imaging features designed to enhance image quality. The main components of the Discovery NM 630 system are: NM Gantry with Dual detector heads, patient table, Remote Control Unit and NM operation console.
FDA Enforcement
Class II
·Terminated·GE Healthcare, LLC·May 8, 2019
Discovery IGS 740 Interventional Fluoroscopic X-ray Systems
FDA Enforcement
Class II
·Terminated·GE Medical Systems, SCS·July 18, 2018
NM/CT 860 Product Usage: The GE NM/CT 860 system is intended for general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body. It includes a general purpose Nuclear Medicine system using a variety of scanning modes supported by various acquisition types, and a Computed Tomography system which is intended for enabling attenuation correction and anatomical localization of SPECT images and for standalone head, whole body and vascular X-ray Computed Tomography applications.
FDA Enforcement
Class II
·Terminated·GE Healthcare, LLC·May 8, 2019
Discovery NM/CT 670 DR Product Usage: The GE Discovery NM/CT 670 system is a medical tool intended for use by appropriately trained health professionals to aid in detecting, localizing, diagnosing of diseases and organ function for the evaluation of diseases, trauma, abnormalities, and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer. The system output can also be used by the physician for staging and restaging of tumors, planning, guiding, and monitoring therapy. The GE Discovery NM/CT 670 system, combining Nuclear Medicine (NM) and Computed Tomography (CT) systems, is intended to produce:
FDA Enforcement
Class II
·Terminated·GE Healthcare, LLC·May 8, 2019
ArcPoint Labs 5 Panel Dip Drug Screen, Part No. APD-5M. The ArcPoint Labs Dip Drug Screen Dip Card is a one-step immunoassay for the qualitative detection of multiple drugs and drug metabolites in human urine.
FDA Enforcement
Class II
·Terminated·Ameditech Inc·October 22, 2014
ArcPoint Labs 10 Panel Dip Screen (OXY), Part No. APD-10MO. The ArcPoint Labs Dip Drug Screen Dip Card is a one-step immunoassay for the qualitative detection of multiple drugs and drug metabolites in human urine.
FDA Enforcement
Class II
·Terminated·Ameditech Inc·October 22, 2014
ArcPoint Labs 10 Panel Dip Screen (BAR), Part No. APD-10M. The ArcPoint Labs Dip Drug Screen Dip Card is a one-step immunoassay for the qualitative detection of multiple drugs and drug metabolites in human urine.
FDA Enforcement
Class II
·Terminated·Ameditech Inc·October 22, 2014
1X1 Cleaving Tiles; The Fiber Cleaver is a reusable and sterilizable tool used to score the outer jacket on Endostat and SureFlex Fibers. The tool is a one piece pencil-like design with a sharpened blade at the end. The Fiber Cleaver is a SureFlex TM Reusable Laser Lithotripsy fiber and EndoStat fiber accessory. The Fiber Cleaver does not come in direct contact with the patient.
FDA Enforcement
Class II
·Terminated·American Medical Systems Innovation Center - Silicon Valley·July 29, 2015
Proteus 235 Proton Therapy System Legacy Software version 7.2.7 and higher, models 110, 112, 113, and 116. Proton therapy
FDA Enforcement
Class II
·Terminated·Ion Beam Applications S.A.·April 30, 2014
Proton therapy system -Proteus 235 aka Proteus Plus. A medical device designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation.
FDA Enforcement
Class II
·Terminated·Ion Beam Applications S.A.·May 24, 2017
Proteus 235, Proton Therapy System
FDA Enforcement
Class II
·Terminated·Ion Beam Applications S.A.·April 26, 2017
Proteus 235, Version PTS-11.0.1.2 and PTS-11.0.2 Product Usage: A device designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation.
FDA Enforcement
Class II
·Terminated·Ion Beam Applications S.A.·July 18, 2018
Proteus 235, Universal Nozzle with snout 300x400; PBS dedicated nozzle with snout XL Product Usage: Device is designed to produce and deliver proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation. The PTS may include a fixed small beam treatment room dedicated to the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation localized to the head and neck.
FDA Enforcement
Class II
·Terminated·Ion Beam Applications S.A.·July 25, 2018