(111 days)
The Wireless/Wired FDR D-EVO flat panel detector system is intended to capture for display radiographic images of human anatomy. It is intended for use in general projection radiographic applications wherever conventional film /screen or CR systems may be used. The FDR D-EVO is not intended for mammography, fluoroscopy, tomography, and angiography applications.
The proposed device, Wireless/Wired FDR D-EVO flat panel detector system, is a modified version of our currently-cleared predicate device, (wired) FDR D-EVO fat panel detector system (DR-ID600), K100762. The predicate device includes the flat panel sensor (DR-ID600SE), which provides only a wired communication mode. The proposed device introduces a modified flat panel detector (DR-ID601SE), which provides both wired and wireless communication modes. The indirect X-ray conversion method using GOS Scintillator, and FUJIFILM's unique Irradiated Side Sampling design, delivering high image quality, remained unchanged in the proposed device. The proposed device is a portable digital detector system that acquires and digitizes xray exposures from standard radiographic systems, which is the same as the predicate device. The proposed device is designed to be used in any environment that would typically use a radiographic cassette. It can be placed in a wall bucky for upright exams, a table bucky for recumbent exams, or removed from the bucky for non-grid exams. All of which are also the same as the predicate device.
This document, K103596, is a 510(k) summary for the Fujifilm Wireless/Wired FDR D-EVO (DR-ID600 w/DR-ID601SE) Flat Panel Detector System. It describes a modified version of a previously cleared device, primarily adding wireless communication capabilities. The entire submission focuses on establishing substantial equivalence to a predicate device and does not involve a clinical study with acceptance criteria for a new device's performance in a diagnostic context. Therefore, it does not contain the information requested in the prompt regarding acceptance criteria, study details, human reader performance, or ground truth establishment.
Specifically, the document emphasizes:
- Substantial Equivalence: The primary goal is to demonstrate that the new device (with wireless capabilities) is substantially equivalent to a previously cleared wired FDR D-EVO system (K100762) and that its wireless specifications are equivalent to another cleared wireless device (Canon CXDI-70C Wireless, K102012).
- Technical Modifications: The key change is the addition of a modified flat panel detector (DR-ID601SE) providing both wired and wireless modes. The indirect X-ray conversion method and irradiated side sampling design remain unchanged.
- Summary of Studies: The document states that the device "successfully completed internal and international IEC testing requirements" and followed the FDA Draft Guidance Document for "Radio-Frequency Wireless Technology in Medical Devices."
Therefore, I cannot provide a table of acceptance criteria, device performance, sample sizes for test or training sets, expert qualifications, adjudication methods, MRMC study details, or ground truth types, as this information is not present in the provided 510(k) summary. The document's purpose is to satisfy regulatory requirements for a modified medical device based on equivalence, not to present a de novo clinical study with specific performance metrics against clinical acceptance criteria.
§ 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.