Falcon/Xpress (Falcon/Xpress)
Viasonix Ltd.The Falcon/Xpress is a compact, portable ultrasonic diagnostic device designed for the noninvasive evaluation of peripheral vascular conditions. It uses pneumatic pressure measurements, Doppler ultrasound, and photo-plethysmography to assess blood flow and vascular health in various limb sites. This helps clinicians diagnose vascular diseases and monitor vascular function with specialized testing protocols.
Intended Use
The Falcon/Xpress is intended for use in the noninvasive evaluation of peripheral vascular pathology in patients. It is used only by trained medical personnel in hospitals, clinics and physicians’ offices by prescription or doctor’s orders.
Technology
The Falcon/Xpress uses pneumatic technology to measure systolic blood pressures and Pulse Volume Recording waveforms at various peripheral limb sites. It includes continuous wave Doppler technology for blood flow velocity measurements and supports Photo-Plethysmography (PPG) technology. The device supports 2 independent pressure channels (expandable to 8), 2 PPG sensors, and 2 Doppler ports. It is compact and portable, supports external battery operation, and interfaces with optional tablet and cart. It performs specialized vascular tests using dedicated protocols.
Performance
The device underwent biocompatibility, electrical safety, mechanical safety, acoustic output, EMC emissions and immunity testing at certified laboratories. Software verification, validation, and performance testing were conducted internally. No clinical studies were performed. Bench testing supports substantial equivalence to the predicate device.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
9/4/2024
3 months - 2
FDA Approval
12/18/2024
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