Orthoscan VERSA Mini C-Arm
Ziehm-Orthoscan, Inc.The Orthoscan VERSA Mini C-Arm is a mobile fluoroscopic X-ray system designed to provide real-time imaging for diagnostic, surgical, and emergency procedures, particularly focused on limbs, extremities, and shoulders. The system enhances clinical workflow by delivering high-quality fluoroscopic images with improved ergonomics and efficiency, helping clinicians to visualize anatomy during treatment.
Intended Use
The Orthoscan VERSA Mini C-arm X-ray system is designed to provide physicians with general fluoroscopic visualization, using pulsed or continuous fluoroscopy, including diagnostic, surgical, and emergency care procedures for all ages, imaging limbs/extremities and shoulders in various settings.
Technology
The system is a modified version of predicate mini C-arm devices, incorporating an upgraded Linux-based OS for improved cybersecurity and functionality, mechanical redesign for better desk top use, improved power management, alternative radiation shielding, and enhanced wireless footswitch communication, while retaining core fluoroscopic imaging functions with a flat panel detector and user-friendly interface.
Performance
The device underwent extensive verification and validation including risk analysis, component and integration testing, and usability studies. Imaging performance was benchmarked against predicates using anthropomorphic phantoms with radiologist assessment confirming equivalent or slightly improved image quality at similar dose levels. Safety and standards compliance were verified by certified test laboratory and no new clinical trials were required.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
11/7/2024
2 months - 2
FDA Approval
1/14/2025
Other devices from Ziehm-Orthoscan, Inc.
- Orthoscan TAU Mini C-Arm2025 • 510K
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.