OPXION Optical Skin Viewer (OPXSV1-01F)
OPXION Technology Inc.The OPXION Optical Skin Viewer is a non-invasive optical coherence tomography system designed to provide real-time visualization of the external tissues of the human body. It generates two-dimensional, cross-sectional, three-dimensional, and en-face images of tissue microstructures, helping clinicians assess skin conditions with high-resolution imaging.
Intended Use
OPXION Optical Skin Viewer is a non-invasive imaging system intended to be used for real-time visualization of the external tissues of the human body. The two-dimensional, cross-sectional, three-dimensional, and en-face images of tissue microstructures can be obtained.
Technology
The device consists of a handheld probe and a mainframe connected by optical fiber. It uses near-infrared light with a superluminescent diode at 840 nm wavelength to produce OCT images. The system provides high-resolution imaging with axial resolution of 7.5 µm and lateral resolution of 10 µm, scanning up to 25 frames per second. It is designed to be smaller and portable compared to predicate devices.
Performance
Performance data showed the device passes applicable IEC, ISO, and ANSI standards (including IEC 62304, IEC 60601-1, IEC 60601-2-22, ISO 10993, IEC 62366). A clinical study with 8 subjects (both healthy and diseased skin) demonstrated the device can reliably capture high-resolution images across various anatomical sites. The scanning procedure was well tolerated with no adverse events. The device's performance was substantially equivalent to the predicate device.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
9/24/2024
9 months - 2
FDA Approval
6/23/2025
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.