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510(k) Data Aggregation
K Number
K192405Device Name
Image Guidance System for Radiotherapy
Manufacturer
Date Cleared
2020-05-01
(241 days)
Product Code
Regulation Number
892.5050Why did this record match?
Applicant Name (Manufacturer) :
Jiangsu Rayer Medical Technology Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Image Guidance System for Radiotherapy is intended to be used in combination with the radiotherapy device, for image-guided positioning verification and real-time tracking of target motion for patient radiation therapy. The Image Guidance System for Radiotherapy sends the positioning data or real-time tracking data to the radiotherapy device but does not control any part of the radiotherapy device.
Device Description
The product is a medical electrical device which is composed of hardware and software, and is jointly used with the radiation therapy device. Image Guidance System for Radiotherapy is intended to be used in combination with the radiotherapy device, for image-guided positioning verification and real-time tracking of target motion for patient radiation therapy.
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