Klarity SGRT System (ARSG-E1A, ARSG-E3A)
Klarity Medical & Equipment (GZ) Co., Ltd.The Klarity SGRT System is a non-invasive, surface-guided radiation therapy device that uses 3D cameras and advanced software to continuously monitor patient positioning and breathing during radiotherapy. It helps clinicians accurately position patients and track respiratory motion to optimize treatment delivery and minimize radiation exposure to healthy tissues.
Intended Use
With radiotherapy equipment (Medical Linac, CT-Sim), it is used for patient positioning before treatment and continuous monitoring of patients during treatment, and can also be used to track patients' breathing mode (including DIBH, EEBH, 4DCT three breathing modes), in order to implement image acquisition synchronized with breathing and radiation therapy.
Technology
A non-irradiating and non-invasive surface guided radiation therapy system consisting of advanced software, PC workstation, one or three 3D cameras, and calibration tools. It uses optical triangulation with structured visible LED light patterns to continuously sense the 3D patient body surface and compare it with prerecorded reference surfaces via 3D image registration. The system outputs six degree-of-freedom positioning deviations to assist manual or automated patient setup and continuously monitors patient motion and respiratory gating during treatment.
Performance
The device underwent non-clinical tests including verification of design specifications, IEC 60601 safety standards, FDA software and cybersecurity guidance compliance, biocompatibility (ISO 10993-1), and usability engineering standards. Performance verification involved testing against device specifications, comparison with predicate devices, and compatibility testing with CT and linear accelerators. No clinical testing was applicable.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
7/2/2024
8 months - 2
FDA Approval
3/18/2025
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