DR 800 with MUSICA Dynamic
Agfa HealthCare N.V.The DR 800 with MUSICA Dynamic by Agfa HealthCare is an advanced fluoroscopic X-ray system designed for dynamic imaging of various body parts, such as gastrointestinal and urogenital tract examinations and angiography. It replaces traditional image intensifier technology with flat-panel digital detectors and incorporates MUSICA Dynamic software for enhanced image processing, improving image quality and aiding clinicians in accurate diagnosis while supporting pediatric and adult imaging needs.
Intended Use
The DR 800 system is indicated for performing dynamic imaging examinations (fluoroscopy and/or rapid sequence) of positioning fluoroscopy procedures, gastro-intestinal examinations, urogenital tract examinations, and angiography. It is intended to replace fluoroscopic images obtained through image intensifier technology and for project radiography of all body parts.
Technology
The DR 800 system is a floor-mounted R/F system comprising a tube, operator console with motorized tilting patient table, bucky with optional wall stand, FLFS overlay, and ceiling suspension. It uses Agfa's NX workstation with MUSICA Dynamic image processing software and flat-panel detectors to capture and digitize digital fluoroscopic images. Its image processing algorithms are similar to those used in other cleared Agfa radiography devices, delivering wide dynamic range images to replace image intensifier technology.
Performance
Performance testing included laboratory and software validation, clinical image quality evaluations by independent radiologists, dose control validation in adult and pediatric phantoms, and usability assessments. Tests confirmed that image quality with MUSICA Dynamic was rated between good and excellent, meeting acceptance criteria. The device complies with safety and electromagnetic standards, with risk assessment confirming no unacceptable risks. No clinical trials were performed.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
3/6/2018
1 month - 2
FDA Approval
4/5/2018
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