XIDF-AWS801, Angio Workstation (Alphenix Workstation), V9.5

Canon Medical Systems Corporation

510k9/12/2023

FDA #

K232526

Product Code

JAA

Panel

Radiology

Modality:Fluoroscopy Task:Detection Body Region:Whole Body

The XIDF-AWS801 Angio Workstation (Alphenix Workstation), V9.5, by Canon Medical Systems is a medical imaging system used alongside interventional angiography equipment. It provides 2D and 3D imaging to assist clinicians in visualizing blood vessels throughout the body during catheter procedures. The device incorporates AI deep learning software to improve the detection and stabilization of stent markers, enhancing image clarity and aiding in diagnosis and treatment planning.

Intended Use

Used in combination with interventional angiography systems to provide 2D and 3D imaging of selective catheter angiography procedures for the whole body including heart, chest, abdomen, brain and extremities. When combined with Dose Tracking System (DTS), it is used for catheter angiography procedures involving heart, chest, abdomen, pelvis and brain.

Technology

Processes input images from diagnostic imaging systems with image processing and display. Includes software changes incorporating deep learning-based Dynamic Device Stabilizer to improve stent marker detection and software improvements for CT DICOM support, 3D roadmap, and dose tracking enhancements.

Performance

Bench testing and risk analysis demonstrated that the V9.5 algorithm improves fixed display performance for Dynamic Device Stabilizer compared to V9.3. Testing confirms system modifications perform equal to or better than the predicate device with compliance to applicable IEC standards.

View FDA documentation

Predicate Devices

No predicate devices specified

Device Timeline

1
Submission
8/21/2023
22 days
2
FDA Approval
9/12/2023

Other devices from Canon Medical Systems Corporation

View all 31 devices

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.