SEGMENTATION ASSISTANT FOR PROSTATE-AUTO CONTOURING— 510(k) K111311

Name: FDA 510(k) clearance K111311
Creator: U.S. Food and Drug Administration
Published: 2011-10-17

Substantially Equivalent

Omisa Inc. (Segasist Technologies)

FDA 510(k) clearance K111311 for SEGMENTATION ASSISTANT FOR PROSTATE-AUTO CONTOURING, Substantially Equivalent on 2011-10-17. Applicant: Omisa Inc. (Segasist Technologies). Device class: 2.

Clearance details

Applicant: Omisa Inc. (Segasist Technologies)
Product code: Code MUJ
Device class: Class 2
Regulation: 21 CFR 892.5050
Advisory panel: Radiology
Date received: 2011-05-10
Decision date: 2011-10-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lakefield, Ontario, CA

Download summary PDF View on FDA.gov ↗

Recent devices under product code MUJ

view all

K260750 — Virtual Cone (1.0)2026-07-08
K253050 — RadOncAI2026-06-18
K260207 — Multimodality Simulation Workspace (MM Sim) (v1.0.0)2026-05-27
K252784 — eXaSkin Plus2026-05-22
K253078 — ART.1-US2026-05-14

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