PRORAD X-Ray Flat Panel Detector with DROC
Prognosys Medical Systems Private LimitedThe PRORAD X-Ray Flat Panel Detector with DROC is a digital radiography system designed to capture and display X-ray images of human anatomy. It is intended for general projection radiographic applications and helps clinicians by digitizing X-ray images for faster, more flexible image viewing and processing. The detector incorporates software that supports image workflow, viewing, measurement, and DICOM connectivity, streamlining radiographic exams and image management in clinical settings.
Intended Use
The PRORAD X-Ray Flat Panel Detector with DROC 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. It is not intended for mammography, fluoroscopy, tomography, and angiography applications. Use is not recommended for pregnant women without physician evaluation.
Technology
The device consists of a flat panel digital detector (wired or wireless) using cesium iodide or gadolinium oxysulfide scintillator to convert X-rays into digital images. It includes proprietary processing software for image acquisition, annotation, storage, image compression, and a Windows PC-based user interface (DROC) to manage exposure workflow, image viewing, measurement, DICOM file input/output, and network integration. The hardware is portable or non-portable, designed for use with conventional X-ray generators, with features such as memory exposure mode and protection against ingress of water.
Performance
Non-clinical testing confirmed compliance with multiple international standards (AAMI/ANSI, IEC series), cybersecurity considerations, risk analysis, load-bearing, ingress protection, and EMC emission tests. Biocompatibility per ISO 10993 was demonstrated and image quality found substantially equivalent to predicate devices. No clinical studies were conducted; equivalence established via non-clinical data.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
3/21/2024
7 months - 2
FDA Approval
11/12/2024
Ready to Sharpen Your Edge?
Join hundreds of your peers who rely on RadAI Slice. Get the essential weekly briefing that empowers you to navigate the future of radiology.
We respect your privacy. Unsubscribe at any time.