meddevicedb.com FDA Device Reference

SEGMENTATION ASSISTANT FOR PROSTATE-AUTO CONTOURING

K111311 Class II Traditional
Decision Date
2011-10-17
Sponsor / Applicant
Omisa Inc. (Segasist Technologies)

Technical Specification

510(k) Submission ID K111311
Product Code MUJ
Medical Specialty / Panel Radiology
Regulation Citation 21 CFR 892.5050
Decision Date 2011-10-17
Clearance Pathway Traditional

Official Documentation

FDA CDRH Summary / statement of record

View FDA Summary PDF

Clearance Summary

SEGMENTATION ASSISTANT FOR PROSTATE-AUTO CONTOURING received FDA 510(k) clearance under submission number K111311, sponsored by Omisa Inc. (Segasist Technologies). The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2011-10-17.

Classification & Regulation

This clearance is catalogued under FDA product code MUJ and 21 CFR 892.5050, within the Radiology review panel as a Class II device.