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510(k) Data Aggregation
K Number
K212606Device Name
BeamSite
Manufacturer
DoseOptics LLC
Date Cleared
2021-09-15
(29 days)
Product Code
IYE, PAN
Regulation Number
892.5050Why did this record match?
Applicant Name (Manufacturer) :
DoseOptics LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The BeamSite™ System is intended to be used only with photon external beam radiotherapy during treatment to acquire and visualize the shape of the treatment radiation beam relative to surface anatomical landmarks on the patient, anywhere in the body where radiation treatment is indicated. BeamSite is used by radiotherapy professionals in appropriate hospital and freestanding radiation therapy environments.
Device Description
BeamSite™ is a camera system that enables live visualization of the treatment beam on a patient during radiotherapy. It is an optically based system that is non-patient contacting and produces no radiation. When the treatment beam is on, BeamSite captures images of Cherenkov light emitted from the patient's skin during radiotherapy to provide an optical map of the treatment beam on the patient. When the treatment beam is off, the system provided continuous background images of the treatment area under ambient light illumination. The BeamSite system consists of a camera, a workstation with preinstalled BeamSite software, and a monitor to be used by clinical radiotherapy teams to a) visually observe the patient and the Cherenkov light emitted from irradiated surface anatomy, and b) review the treatment images, if necessary.
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K Number
K200940Device Name
BeamSite
Manufacturer
DoseOptics LLC
Date Cleared
2020-12-11
(247 days)
Product Code
IYE, PAN
Regulation Number
892.5050Why did this record match?
Applicant Name (Manufacturer) :
DoseOptics LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The BeamSite™ System is intended to be used only with photon external beam radiotherapy during treatment to acquire and visualize the shape of the treatment radiation beam relative to surface anatomical landmarks on the patient, anywhere in the body where radiation treatment is indicated. BeamSite is used by radiotherapy professionals in appropriate hospital and freestanding radiation therapy environments.
Device Description
BeamSite™ is a system that enables real-time visualization of the treatment beam on a patient during radiotherapy. It is an optically based system that is non-patient contacting and produces no radiation. BeamSite captures images of Cherenkov light emitted from the patient's skin during radiotherapy to provide an optical map of the beam on the patient. The BeamSite system consists of a camera, workstation with pre-installed BeamSite software and a monitor to be used by clinical radiotherapy teams to visually observe the treatment, as it happens, and review after the treatment, if necessary.
The BeamSite system is designed to be used as a fixed mounted camera having a field of view of the treatment area, to routinely image patient treatments with minimal impact to the clinical workflow. The video images produced are intended to provide additional information about the treatment for the clinical team by displaying the beam size and shape on the patient during treatment. The images produced will provide real-time, direct visual indication that the beam is on, that it is impacting the patient at the intended treatment surface, provides visual feedback regarding the patient's movement relative to the beam, and that surfaces of the body not intended for treatment remain outside the beam path. BeamSite is to be used as a visualization tool. Therapeutic decisions should not be made solely based on the images acquired from this device. However, the images will provide a simple and intuitive means to visually monitor radiation therapy on a routine basis.
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