meddevicedb.com FDA Device Reference

PROSTATE MECHANICAL IMAGER

DEN100016 Class II Post-NSE
Decision Date
2012-04-27
Sponsor / Applicant
Artann Laboratories, Inc.

Technical Specification

510(k) Submission ID DEN100016
Product Code OQT
Medical Specialty / Panel Gastroenterology, Urology
Regulation Citation 21 CFR 876.2050
Decision Date 2012-04-27
Clearance Pathway Post-NSE

Official Documentation

No FDA summary/statement PDF is linked for this clearance in the current dataset. Consult the product code and regulation citation above to locate predicate documentation.

Clearance Summary

PROSTATE MECHANICAL IMAGER received FDA 510(k) clearance under submission number DEN100016, sponsored by Artann Laboratories, Inc.. The device was reviewed via the Post-NSE premarket notification pathway and assigned to the Gastroenterology, Urology review panel. The statutory decision date of record is 2012-04-27.

Classification & Regulation

This clearance is catalogued under FDA product code OQT and 21 CFR 876.2050, within the Gastroenterology, Urology review panel as a Class II device.