(45 days)
This device is intended to be used in the fluoroscopy and fluorography.
This device is operated and used by Physicians and X-ray technologist.
The object of this device is total patient population.
As mentioned at "Intended Use" in this notification, the intended use of the IA-16L/HS is the same as that of predicate device IA-16LM.
Consequently, the indications for use of the IA-16L/HS are also the same as that of the IA-16LM and there are no additional indications.
Not Found
The provided text is a 510(k) premarket notification letter from the FDA to Shimadzu Corporation for their "Shimadzu Image Amplifier IA-16L/HS." This document does not contain any information regarding acceptance criteria, device performance tables, sample sizes, ground truth establishment, or study methodologies.
The letter is a notification of substantial equivalence, stating that the device is equivalent to legally marketed predicate devices and can therefore be marketed. It outlines regulatory information such as the regulation number, regulatory class, and product code, along with general controls provisions of the Act. The document concludes with the "Indications For Use" for the device, stating it's intended for fluoroscopy and fluorography, to be used by physicians and x-ray technologists, and for the total patient population, aligning with its predicate device IA-16LM.
Therefore, I cannot provide the requested information based on the given input, as the document does not describe a study or its results.
§ 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.