X Sensor (Model: IOS-A15IF, HDI-15DGF)
Qpix Solutions IncX Sensor is a digital intraoral dental x-ray sensor that captures x-ray photons and instantly converts them to digital images for dentists to view and analyze. It enhances dental diagnostic workflows by providing faster image acquisition with high resolution and image quality, making diagnosis more efficient and reliable.
Intended Use
X Sensor is intended to collect dental x-ray photons and convert them into electronic impulses that may be stored, viewed and manipulated for diagnostic use by dentists.
Technology
X Sensor is a direct conversion digital intraoral sensor using a photoconductor (CsPbBr3) and single crystal silicon to acquire high resolution images almost instantaneously. It includes integrated USB 2.0 connectivity and imaging software (EzDent-i) for image viewing and manipulation.
Performance
Performance testing showed that X Sensor performs equivalently or better than the predicate device (EzSensor XHD) in image quality metrics such as DQE and MTF, with no additional safety risks identified. Safety, electrical, mechanical, environmental, and cybersecurity tests were conducted per relevant IEC standards and FDA guidance. Clinical images demonstrated comparable diagnostic quality to the predicate device.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
9/13/2024
28 days - 2
FDA Approval
10/11/2024
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