(261 days)
Radiaction's Shield System is intended for reducing unnecessary exposure to scatter X-ray radiation of medical teams during fluoroscopy-guided procedures with the Toshiba Infinix-I C-arm, by attenuating scatter radiation. It is not intended to be used with such procedures for head and neck areas.
Not Found
This FDA clearance letter does not contain the detailed information required to answer your request about acceptance criteria and the study proving the device meets those criteria.
The letter mentions the device (Shield System), its intended use (reducing scatter X-ray radiation exposure during fluoroscopy-guided procedures), and the specific C-arm it's compatible with (Toshiba Infinix-I C-arm). However, it does not include:
- A table of acceptance criteria or reported device performance.
- Details about a study (sample size, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types).
- Information on training set sample size or ground truth establishment for training.
This document is primarily a formal notification of a device being granted 510(k) clearance by the FDA, indicating substantial equivalence to a predicate device. It confirms the device can be legally marketed but does not delve into the specifics of the pre-clinical or clinical studies conducted to support that clearance. Such detailed study information is typically found in the 510(k) summary or the full 510(k) submission, neither of which is present in the provided text.
§ 892.1650 Image-intensified fluoroscopic x-ray system.
(a)
Identification. An image-intensified fluoroscopic x-ray system is a device intended to visualize anatomical structures by converting a pattern of x-radiation into a visible image through electronic amplification. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). An anthrogram tray or radiology dental tray intended for use with an image-intensified fluoroscopic x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9. In addition, when intended as an accessory to the device described in paragraph (a) of this section, the fluoroscopic compression device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.