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U.S. Department of Health and Human Services

Product Classification

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Device prostate lesion, documentation, system
Definition Produces an elasticity image of the prostate to document prostate abnormalities that were previously identified by digital rectal examination.
Physical State Cart-based system consisting of a hand-held rectal probe attached to a computer with proprietary image reconstruction software.
Technical Method Uses an array of pressure sensors and image reconstruction software to create a 3-D map showing areas of relative tissue hardness or softness within the prostate.
Target Area Prostate, rectum.
Regulation Medical Specialty Gastroenterology/Urology
Review Panel Gastroenterology/Urology
Product CodeOQT
Premarket Review Reproductive, Gynecology and Urology Devices (DHT3B)
Reproductive, Gynecology and Urology Devices (DHT3B)
Submission Type 510(k)
Regulation Number 876.2050
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible