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U.S. Department of Health and Human Services

Product Classification
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Device prostate lesion, documentation, system
Regulation Description 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
Reporting		 Eligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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