OQT

Prostate Lesion, Documentation, System

Product code

OQT

Device name

Prostate Lesion, Documentation, System

Device class

Class 2

21 CFR

21 CFR 876.2050

Medical specialty

Gastroenterology, Urology

Marketing pathway

510(K)

510(k) clearances (all years, FDA)

1 (all years; only the last 3 years are listed here)

FDA classification definition

Produces an elasticity image of the prostate to document prostate abnormalities that were previously identified by digital rectal examination.

Definition text from the FDA device classification database (U.S. federal government work, public domain).