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    BeamMed Ltd.

    FDA registration
    BeamMed Ltd.·1 product·🇮🇱 Israel

    BeamMed

    FDA UDI
    BEAMMED LTD·07299012704119·"Omnisense 7000: The Sunlight Omnisense Ultraso...

    BeamMed

    FDA UDI
    BEAMMED LTD·07290012704109·"Sunlight MiniOmni: The Sunlight MiniOmni Ultra...

    BeamMed

    FDA UDI
    BEAMMED LTD·72990012704126·"Tetrax balance assessment is used to quantitat...

    Sterigenics Shanghai E Beam Ltd.

    FDA registration
    Sterigenics Shanghai E Beam Ltd.·13 products·🇨🇳 China

    PLASMAJET SYSTEM

    FDA Adverse Event
    Other ·PLASMA SURGICAL LTD·Product code GEI·January 30, 2007

    ELEKTA MEDICAL LINEAR ACCELERATOR

    FDA Adverse Event
    Injury ·ELEKTA LTD·Product code IYE·August 31, 2023

    VERSA HD

    FDA Adverse Event
    Injury ·ELEKTA LTD·Product code IYE·October 26, 2023

    LENSX LASER SYSTEM

    FDA Adverse Event
    Malfunction ·ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER·Product code OOE·September 2, 2022

    PANORAD

    FDA Adverse Event
    Malfunction ·ARCOMA AB·Product code KPR·February 1, 2018

    BRAINLAB EXACTRAC VERO, Model/Catalog Numbers: 46228 EXACTRAC VERO 3.5 46238 EXACTRAC VERO 3.5 46216 EXACTRAC VERO SW UPDATE 3.5.2 TO 3.5.3 46218 EXACTRAC VERO SW UPDATE 3.5.3 TO 3.5.4 The ExacTrac Vero system is intended to be used in conjunction with the MHI-TM2000 Radiation Therapy Linear Accelerator System manufactured by Mitsubishi Heavy Industries, Ltd. ExacTrac Vero uses the images received from the MHI-TM2000 linear accelerator for analyzing the current patient position and calculating - when applicable - a necessary correction shift. The correction shift is then exported to the MHI-TM2000 linear accelerator. The ExacTrac Vero system uses stereoscopic X-ray or Cone Beam CT registration and optical tracking of infrared reflective markers in order to localize and correct the patient position before and during treatment. Optionally ExacTrac Vero provides position data for the pan/tilt motion of the MHI-TM2000 gantry head to the MHITM2000 controller for continuous alignment of the beam orientation with a moving target. The position data is based on target detection via X-ray imaging and IR tracking of external surrogate markers.

    FDA Enforcement
    Class II ·Terminated·Brainlab AG·December 6, 2017

    ITERO ELEMENT FLEX

    FDA Adverse Event
    Injury ·ALIGN TECHNOLOGY, LTD.·Product code NOF·May 10, 2024

    AlignRT¿ Plus [private label-OSMS] K123371: The AlignRT Plus system is indicated for use to position and monitor patients relative to the prescribed treatment isocentre, and to withhold the beam automatically during radiation delivery.

    FDA Enforcement
    Class II ·Terminated·Vision RT Ltd·August 31, 2016

    AlignRT Plus [private label-OSMS] K123371: The AlignRT Plus system is indicated for use to position and monitor patients relative to the prescribed treatment isocentre, and to withhold the beam automatically during radiation delivery.

    FDA Recall
    Terminated ·Vision RT Ltd Dove House, Arcadia Avenue London United Kingdom·Product code IYE·June 30, 2016

    Ellex Medical Fixed eye Safety filters Model Integre S LP5532. The filter is located in the binocular mount of the laser delivery head. The filter prevents transmission of treatment laser light to physician eyes while the aiming beam to remain visible. .

    FDA Recall
    Terminated ·Laserex Systems Inc.·Product code HQF·February 1, 2016

    Brand Name: Hitachi Proton Beam Therapy REF: PROBEAT-CR

    FDA Recall
    Open, Classified ·Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha 44-141-1, W 226 Wakashiba Kashiwa Japan·Product code LHN·February 6, 2026

    Brand Name: Hitachi Proton Beam Therapy System Ref: PROBEAT-FR

    FDA Recall
    Open, Classified ·Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha 44-141-1, W 226 Wakashiba Kashiwa Japan·Product code LHN·February 6, 2026

    BRAINLAB EXACTRAC VERO, Model/Catalog Numbers: 46228 EXACTRAC VERO 3.5 46238 EXACTRAC VERO 3.5 46216 EXACTRAC VERO SW UPDATE 3.5.2 TO 3.5.3 46218 EXACTRAC VERO SW UPDATE 3.5.3 TO 3.5.4 The ExacTrac Vero system is intended to be used in conjunction with the MHI-TM2000 Radiation Therapy Linear Accelerator System manufactured by Mitsubishi Heavy Industries, Ltd. ExacTrac Vero uses the images received from the MHI-TM2000 linear accelerator for analyzing the current patient position and calculating - when applicable - a necessary correction shift. The correction shift is then exported to the MHI-TM2000 linear accelerator. The ExacTrac Vero system uses stereoscopic X-ray or Cone Beam CT registration and optical tracking of infrared reflective markers in order to localize and correct the patient position before and during treatment. Optionally ExacTrac Vero provides position data for the pan/tilt motion of the MHI-TM2000 gantry head to the MHITM2000 controller for continuous alignment of the beam orientation with a moving target. The position data is based on target detection via X-ray imaging and IR tracking of external surrogate markers.

    FDA Recall
    Terminated ·Brainlab AG Olof-Palme-Strasse 9 Munich Germany·Product code IYE·November 3, 2017

    THREE BEARS (JIANGSU) HEALTHCARE TECHNOLOGY CO. LTD.

    FDA registration
    THREE BEARS (JIANGSU) HEALTHCARE TECHNOLOGY CO. LTD.·6 products·🇨🇳 China

    CHANGZHOU 3 BEARS IMPORT/EXPORT CO. LTD

    FDA registration
    CHANGZHOU 3 BEARS IMPORT/EXPORT CO. LTD·5 products·🇨🇳 China