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510(k) Data Aggregation
(56 days)
TheraView TBI
Digital Portal imaging system designed to allow pre-treatment verification and real time viewing of the radiation therapy treatment. Images maybe stored to hard disk for processing, analysis and hardcopy. This includes an automated border detection for field size and shape verification and a semi-automated overlay function of an anatomical template reference adding enhanced level of on-line assurance for image verification and comparison.
Digital Portal imaging system designed to allow pre-treatment verification and real time viewing of the radiation therapy treatment. Images maybe stored to hard disk for processing, analysis and hardcopy. This includes an automated border detection for field size and shape verification and a semi-automated overlay function of an anatomical template reference adding enhanced level of on-line assurance for image verification and comparison.
I am sorry, but the provided text does not contain information about acceptance criteria, device performance, sample sizes for test or training sets, data provenance, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone performance, or types of ground truth. The document is an FDA 510(k) clearance letter for the TheraView TBI Imager, which primarily states that the device is substantially equivalent to a legally marketed predicate device and outlines regulatory compliance requirements and the device's indications for use.
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(77 days)
THERAVIEW
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