Product code OQT— Gastroenterology, Urology

PROSTATE MECHANICAL IMAGER

Classification name: Prostate Lesion, Documentation, System
Device class: Class 2
Regulation: 21 CFR 876.2050
Advisory panel: Gastroenterology, Urology
Total cleared: 1
First cleared: 2012-04-27
Most recent: 2012-04-27

FDA classification definition

“Produces an elasticity image of the prostate to document prostate abnormalities that were previously identified by digital rectal examination.”
— U.S. Food and Drug Administration, device classification record for product code OQT under 21 CFR 876.2050, via openFDA

Market context for product code OQT

FDA has cleared 1 device under product code OQT, all in 2012, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Top applicants under product code OQT

Artann Laboratories, Inc.1 clearance

Recent clearances under product code OQT

DEN100016 — PROSTATE MECHANICAL IMAGERArtann Laboratories, Inc.·2012-04-27

Data sourced from openFDA. This site is unofficial and independent of the FDA.