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510(k) Data Aggregation
K Number
K201591Device Name
Flat Panel Detector
Manufacturer
Date Cleared
2020-09-03
(83 days)
Product Code
Regulation Number
892.1680Why did this record match?
Applicant Name (Manufacturer) :
KA Imaging Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The flat panel detector when used with a radiographic imaging system is intended to generate radiographic images of human anatomy wherever a conventional screen-film, digital radiography (DR) or computed radiography (CR) detector is used for general purposes.
When the dual energy subtraction is enabled, it is intended to assist the physician through the visualization of anomalies by reducing the visibility of underlying or overlying anatomical structures.
This device is not intended for use in mammography applications.
Device Description
The Reveal 35C Flat Panel Detector is similar to the FDA cleared Yushan X-ray Flat Panel Detector. The detectors consist of amorphous silicon flat panel image sensors with cesium iodide scintillators. The light is captured by an amorphous silicon photodetector and the resulting signal is transferred via amorphous silicon thin film transistor (TFT) switches to external readout electronics to obtain X-ray images. The Reveal 35C Flat Panel Detector is a portable digital detector that can be integrated with a PC workstation and an X-ray source to acquire digital X-Ray images for general radiography. The detector supports wireless and wired data communication and can be used wherever a conventional screen-film, digital radiography, or computed radiography detector is used for general purposes.
The Reveal 35C Flat Panel Detector synchronize their image capture cycle with the X-Ray exposure in either of the two modes:
- 1. Wired Mode
- Wireless Mode 2.
The subject device, Reveal 35C Flat Panel Detector includes an optional Dual-Energy subtraction function. When the Dual-Energy Subtraction function is enabled, it will provide additional dual energy subtracted X-ray images. The images are intended to assist the physician through the visualization of anomalies by reducing the visibility of underlying or overlying anatomical structures.
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