INNOVISION-EXII
DK Medical SystemThe INNOVISION-EXII is a stationary digital radiography X-ray system designed for obtaining radiographic images of various anatomical parts of the human body in clinical environments. It supports imaging for both pediatric and adult patients, converting X-ray signals into digital DICOM images to assist clinicians in diagnostic screening. The system incorporates imaging software for processing images and is operated by trained radiologic technologists. It is suitable for imaging areas such as head, spine, chest, and abdomen and is not intended for mammography, angiography, interventional, or fluoroscopy uses.
Intended Use
INNOVISION-EXII is a stationary X-ray system intended for obtaining radiographic images of various anatomical parts of the human body, both pediatrics and adults, in a clinical environment. It is not intended for mammography, angiography, interventional, or fluoroscopy use.
Technology
The INNOVISION-EXII receives X-ray signals from irradiation, digitizes them into X-ray images using Elui imaging software which converts images into DICOM format. It includes a digital radiography X-ray system that integrates a GUI-based operator console, high voltage X-ray generator, patient table, detector stands, and imaging software for image acquisition, processing, and management.
Performance
Non-clinical testing included compliance with electrical safety standards IEC 60601-1 and IEC 60601-1-2, software validation and verification, and performance testing following multiple IEC and FDA standards. Clinical image evaluation confirmed that INNOVISION-EXII generates images with appropriate quality for diagnostic examination. The device was found substantially equivalent and as safe and effective as the predicate device.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
7/19/2024
5 months - 2
FDA Approval
1/3/2025
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.