1 breast lesion documentation system suppliers
U-Systems, Inc.
Sunnyvale, California U-Systems, Inc. specializes in breast imaging. Our Somo.v™ automated breast ultrasound methodically scans a woman7#39;s breast, capturing up to 350 ultrasound images that can be rendered and reviewed in 3D. Our proprietary technology combines several ultrasound frames together, to determine an More...
www.u-systems.com
Sunnyvale, California U-Systems, Inc. specializes in breast imaging. Our Somo.v™ automated breast ultrasound methodically scans a woman7#39;s breast, capturing up to 350 ultrasound images that can be rendered and reviewed in 3D. Our proprietary technology combines several ultrasound frames together, to determine an More...
www.u-systems.com
1 suppliers
Breast Lesion Documentation System Manufacturers
FDA Code / Regulation: NKA / 884.2990 FDA Device Name: System, Documentation, Breast Lesion
Identification. A breast lesion documentation system is a device for use in producing a surface map of the breast as an aid to document palpable breast lesions identified during a clinical breast examination.
Classification. Class II (special controls). The special control is FDA's guidance entitled "Class II Special Controls Guidance Document: Breast Lesion Documentation System." See 884.1(e) for the availability of this guidance document.
A Breast lesion documentation device is a device for recording and documenting palpable breast lesions detected during a clinical breast exam.
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