(309 days)
The iDR is indicated for use in generating diagnostic medical x-rays images of human anatomy. It is intended to replace radiographic film/ screen systems in all general - purpose diagnostic radiographic procedures. It is not intended for mammography applications.
Not Found
This document is a 510(k) clearance letter from the FDA for the iDR device, an x-ray system. It does not contain any information regarding acceptance criteria or a study proving the device meets acceptance criteria.
The letter primarily:
- Acknowledges the submission and the substantial equivalence to a predicate device.
- Outlines regulatory requirements for the device.
- Specifies the "Indications for Use" for the iDR, which is "generating diagnostic medical x-rays images of human anatomy. It is intended to replace radiographic film/screen systems in all general-purpose diagnostic radiographic procedures." It also explicitly states, "It is not intended for mammography applications."
Therefore, I cannot provide the requested information based on the provided text.
§ 892.1680 Stationary x-ray system.
(a)
Identification. A stationary x-ray system is a permanently installed diagnostic system intended to generate and control x-rays for examination of various anatomical regions. 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). A radiographic contrast tray or radiology diagnostic kit intended for use with a stationary 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.