(118 days)
TiGRT IVS is intended to be used in conjunction with Linac and Digital Panel for analyzing the current patient position and calculating the patient positioning shift correction factor, as well as the treatment portal verification and record.
TiGRT IVS is intended to be used in conjunction with Linac and Digital Panel for analyzing the current patient position and calculating the patient positioning shift correction factor, as well as the treatment portal verification and record.
The provided text does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.
The document is a 510(k) premarket notification for an image viewing system called TiGRT IVS. It primarily focuses on demonstrating substantial equivalence to a predicate device (ExacTrac K072046) based on intended use, design, and performance characteristics.
Here's what the document does include:
- Device Name: TiGRT IVS
- Intended Use: To be used in conjunction with Linac and Digital Panel for analyzing the current patient position, calculating patient positioning shift correction factor, and for treatment portal verification and record.
- Predicate Device: ExacTrac (K072046)
- Classification: Class II device (21 CFR 892.5050)
- Comparison with Predicate Device: A table comparing characteristics like operating system, networking, intended use, application, and DICOM compatibility. All characteristics are either identical or considered substantially equivalent.
Therefore, I cannot provide the requested information in the table format because the source text does not contain it. This type of document (a 510(k) summary) focuses on substantial equivalence rather than explicit performance data against acceptance criteria.
§ 892.5050 Medical charged-particle radiation therapy system.
(a)
Identification. A medical charged-particle radiation therapy system is a device that produces by acceleration high energy charged particles (e.g., electrons and protons) intended for use in radiation therapy. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts, and accessories.(b)
Classification. Class II. When intended for use as a quality control system, the film dosimetry system (film scanning system) included as an accessory to the device described in paragraph (a) of this section, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.