(30 days)
Edge Air Digital Flat Panel X-Ray Detector is indicated for digital imaging solution designed for general radiographic system for human anatomy. It is intended to replace film or screen based radiographic system in all general purpose diagnostic procedures. Not to be used for mammography.
Edge Air is a wired/wireless digital solid state X-ray detector that is based on flat-panel technology. The wireless LAN (IEEE 802.11a/g/n/ac) communication signals images captured to the system and improves the user operability through high-speed processing. This radiographic image detector and processing unit consists of a scintillator coupled to an a-Si TFT sensor. This device needs to be integrated with a radiographic imaging system. It can be utilized to capture and digitalize Xray images for radiographic diagnosis The RAW files can be further processed as DICOM compatible image files by a separate console SW program (K160579 / Xmaru View V1 and Xmaru PACS/ Rayence Co., Ltd.) for a diagnostic analysis.
This document describes the equivalence of the OSKO, INC. Edge Air Digital Flat Panel X-ray Detector to a predicate device, the Rayence Co., Ltd. 1717WCC. The focus is on demonstrating that the Edge Air performs similarly to the predicate device, rather than establishing novel acceptance criteria for improved diagnostic accuracy.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a substantial equivalence submission, the "acceptance criteria" are primarily based on demonstrating similar performance to the predicate device. The performance metrics are reported in terms of comparison.
| Acceptance Criteria (Comparison to Predicate) | Reported Device Performance (Edge Air vs. 1717WCC) |
|---|---|
| Intended Use | Same |
| Detector Type | Same (Amorphous Silicon, TFT) |
| Scintillator | Same (CsI:T1) |
| Imaging Area | Same (17 x 17 inches) |
| Pixel Matrix | Same (3072 X 3072) |
| Pixel Pitch | Same (140 um) |
| Resolution | Same (3.9 lp/mm) |
| A/D Conversion | Same (14 / 16 bit) |
| Preview Time | Same ( |
§ 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.