510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K111311Substantially Equivalent

Segmentation Assistant for Prostate-Auto Contouring

Omisa Inc. (Segasist Technologies), Lakefield, Ontario, CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K111311 is the FDA 510(k) clearance record for SEGMENTATION ASSISTANT FOR PROSTATE-AUTO CONTOURING, a class II device, cleared for Omisa Inc. (Segasist Technologies) on under FDA product code MUJ (System, Planning, Radiation Therapy Treatment). FDA records list one 510(k) clearance for Omisa Inc. (Segasist Technologies). As of , FDA records show no recalls naming K111311.

Clearance record

Decision date
Received
(160 days to decision)
Product code
MUJ System, Planning, Radiation Therapy Treatment
Regulation
21 CFR 892.5050
Device class
Class II
Review panel
Radiology
Applicant
Omisa Inc. (Segasist Technologies) 1666 12th Line, Rr #3, Lakefield, Ontario, CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code MUJ

Trailing 12 months
13 clearances under product code MUJ in the twelve months to October 2026, December 2025 the highest month at 3.
Show the numbers
Monthly 510(k) clearances under FDA product code MUJ, trailing twelve months
MonthClearances
November 20251
December 20253
January 20260
February 20262
March 20261
April 20260
May 20263
June 20261
July 20261
August 20260
September 20260
October 20261