OQT · Class II · 21 CFR 876.2050

FDA Product Code OQT: Prostate Lesion, Documentation, System

Produces An Elasticity Image Of The Prostate To Document Prostate Abnormalities That Were Previously Identified By Digital Rectal Examination.

Leading manufacturers include Artann Laboratories, Inc..

1
Total
0
Cleared
707d
Avg days
2012
Since

FDA 510(k) Cleared Prostate Lesion, Documentation, System Devices (Product Code OQT)

1 devices
1–1 of 1
Not Cleared Apr 27, 2012
PROSTATE MECHANICAL IMAGER
DEN100016
Artann Laboratories, Inc.
Gastroenterology & Urology · 707d

About Product Code OQT - Regulatory Context