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Breast Lesion Documentation System Suppliers

 EMAIL INQUIRY to  2 suppliers  
Medical Tactile, Inc. | Address: 5757 W. Century Blvd #600, Los Angeles, California 90045, USA USA
www.medicaltactile.com | Send Inquiry | Phone: +1-(310)-641-8228
FDA Registration: 3005735227  Annual Revenues: USD 1-5 Million  Employee Count: ~20
Products: Diagnostic Aids, Breast Cancer Test, Breast Cancer Detection Kit Test, Breast Lesion Documentation System (FDA Code: NKA), ...
Medical Tactile, Inc. is a provider of diagnostic device for breast cancer screening. We offer SureTouch Exam™ which is a painless way to enhance routine clinical breast exam. It is ideal for wo more...
 
U-Systems, Inc. | Address: 447 Indio Way, Sunnyvale, California 94085, USA USA
www.u-systems.com | Phone: +1-(408)-390-7479
FDA Registration: 2954903  Year Established: 1997
Products: Ultrasounds, Mammography Devices, Ultrasound Transducers, Product Development, Breast Cancer Screening Device, Ultrasound System, Breast Lesion Documentation System (FDA Code: NKA), ...
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 rev more...
 EMAIL INQUIRY to  2 Breast Lesion Documentation System suppliers  
FDA Code / Regulation: NKA / 884.2990

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.

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