Dental CBCT X-ray System
Yian Medical Technology (Haining) Co., Ltd.The Dental CBCT X-ray System by Yian Medical Technology is a dental imaging device that produces 2D panoramic, cephalometric images, and 3D cone-beam CT images of the dental, oral, and maxillofacial region. It aids healthcare professionals in diagnosing adult and pediatric patients, providing detailed digital X-ray images for dental and oral care.
Intended Use
The device is intended to produce two-dimensional digital X-ray images including panoramic and cephalometric image, and three-dimensional digital X-ray images of the dental, oral, maxillofacial region, at the direction of healthcare professionals as diagnostic support for adult and pediatric patients.
Technology
Uses cone-beam computed tomography (CBCT) with an integrated X-ray source tube, collimator, flat panel detector (CsI), image processing computer and software workstation producing 3D and 2D dental images (panoramic and cephalometric).
Performance
No new bench or clinical testing was needed since the device modifications have no impact on design, function, or performance compared to the predicate. Device passed electrical safety, EMC, radiation safety, and usability standards per IEC and ISO. The non-clinical testing demonstrated equivalence to the predicate device.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
5/29/2025
29 days - 2
FDA Approval
6/27/2025
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.