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510(k) Data Aggregation
(253 days)
EDGE MEDICAL DEVICES LTD.
The Quix Digital Radiography Upgrade is based on a solid state imaging device and is intended for use in general radiographic examinations and applications wherever conventional film-screen systems may be used, excluding mammography, fluoroscopy, and angiography.
The Quix Digital Radiography Upgrade enables a conventional film-screen X-ray system to perform digital radiography exams by replacing the film-screen and the film-screen bucky with a digital bucky and operator console. The digital bucky incorporates a selenium-based flat panel detector with 16" x 17" imaging area. Images are displayed in approximately 10 seconds after exposure over a wide range of dose settings. The operator console provides local image storage and communicates with other network devices using DICOM 3.0 protocols.
The provided text is a 510(k) summary for the "Quix Digital Radiography Upgrade" device. This document is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to legally marketed predicate devices. It focuses on comparing the new device's technical specifications and intended use against existing products.
Crucially, this document does not contain a study that proves the device meets acceptance criteria in the format typically used for performance claims of AI/ML-based devices (e.g., sensitivity, specificity, AUC, human reader studies).
Instead, the acceptance criteria for this type of device (a digital X-ray system) and the "study" demonstrating its equivalence are based on a comparison of its physical and performance specifications to those of existing, legally marketed predicate devices. The "acceptance criteria" are implied by the performance metrics of the predicate devices.
Here's an attempt to extract and interpret the information based on the provided text, acknowledging the limitations inherent in a 510(k) for a non-AI/ML device:
1. Table of acceptance criteria and the reported device performance
For a device like the Quix Digital Radiography Upgrade, the "acceptance criteria" are implicitly defined by the performance characteristics of its predicate devices. The "reported device performance" is the specifications of the Quix DR Upgrade.
| Item (Performance Characteristic) | Acceptance Criterion (Predicate Device Performance) - Infimed Stingray DR Upgrade (K992794) used as the primary predicate for technical comparison | Reported Device Performance (Quix DR Upgrade) |
|---|---|---|
| Intended Use | Provide diagnostic images for general radiographic use, excluding mammography, fluoroscopy, and angiography. | Provide diagnostic images for general radiographic use, excluding mammography, fluoroscopy, and angiography. |
| Anatomical Sites | General radiography | General radiography |
| Target Population | General population | General population |
| Design | Digital acquisition, electronic processing | Digital acquisition, electronic processing |
| X-ray Converter | Cesium Iodide scintillator, converts X-rays to light | Amorphous selenium, converts X-rays to latent charge image |
| Image Readout | Photodiode and TFT amorphous silicon active matrix array convert light to electrical charge which is readout electronically. | Plasma DR Readout Technology – line scanner sweeps across sensor surface to readout latent charge image. |
| Moving line scanner | No | Yes |
| Performance (Image Processing) | Digital image processing (optimized gray scale) | Digital image processing (optimized gray scale) |
| Imaging Area | 17" x 17" | 16" x 17" |
| Monolithic sensor | No (tiled subarrays) | Yes |
| Pixel array size | 2981 x 3021 (from 510(k)) / 3000 x 3000 (current "chart smart") | 2540 x 2700 |
| Pixel size | 143 $\mu m$ | 160 $\mu m$ |
| Dynamic Range | 14 bits (16,384) | 12 bits (4,096) |
| Connectivity | DICOM 3.0 Compatible | DICOM 3.0 Compatible |
| Image processing time |
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