Adora DRFi (04550010)
NRT X-Ray A/SThe Adora DRFi is a ceiling suspended, universal X-ray system designed for diagnostic radiography and fluoroscopy. It supports a wide range of whole-body X-ray examinations in both adult and pediatric patients and features a flat panel detector for direct radiography and radioscopy. The system improves ergonomics and workflow while enabling imaging in various patient positions including supine, standing, sitting, wheelchair, or stretcher. It is intended for use by trained healthcare professionals and is not for mammography.
Intended Use
The Adora DRFi is a direct radiography and radioscopy, universal and permanently installed diagnostic X-ray system with a flat panel detector, which allows acquisition of a wide range of X-ray examinations of the entire body including adult and pediatric patients in various positions, intended for use by trained personnel. Not for mammography examinations.
Technology
The device is a ceiling suspended universal X-ray system utilizing a flat panel detector (Canon CXDI-RF Wireless B1) and Canon CXDI imaging software for image acquisition and post processing, enabling radiographic and fluoroscopic imaging. The system includes a floor-mounted patient table with floating top and an 80kW X-ray generator. Movements of the X-ray tube and flat panel are synchronized for rotation and positioning controlled by operator input (joystick or pre-programmed auto-positions).
Performance
Testing demonstrates the Adora DRFi performs as safely and effectively as its predicate device, the Siemens Multitom Rax (K152928). It complies with applicable international standards (IEC 60601 series) and FDA performance standards, and design and production controls follow QMS standards ISO 13485 and 21 CFR 820.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
9/25/2024
2 months - 2
FDA Approval
12/23/2024
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