IODR1717 / IODR1417 / IODR1417-GF (Digital Flat Panel X-ray Detector)
Aspen Imaging Healthcare IncThe IODR1717 / IODR1417 / IODR1417-GF detectors are digital flat panel X-ray detectors designed for high-quality digital radiography in general anatomical imaging for adults and children. They replace film-based systems and facilitate faster, streamlined digital radiography with wireless or wired connectivity, enhancing image acquisition and processing for clinicians.
Intended Use
The IODR1717 / IODR1417 / IODR1417-GF (Digital Flat Panel X-Ray Detector) is indicated as a digital imaging solution designed for providing the general radiographic diagnosis of human anatomy targeting both adults and children. It is intended to replace film-based radiographic diagnostic systems. Not to be used for mammography.
Technology
The device uses thin film technology based on amorphous silicon (a-Si) TFT sensors combined with a cesium iodide (CsI) scintillator. It supports wired or wireless data transmission, auto-trigger signal sensing technology without generator integration, and includes software for generator and detector control, image acquisition, calibration, correction, and storage.
Performance
The device complies with electrical safety and electromagnetic compatibility standards (IEC 60601-1, IEC 60601-1-2, IEC 62220-1-1). Software validation was performed following FDA guidance. Imaging performance was evaluated per IEC 62220-1 standards, demonstrating comparable detective quantum efficiency (DQE) to the predicate device K223930. No clinical data were provided.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
5/13/2024
5 months - 2
FDA Approval
11/7/2024
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