SIMULIX EVOLUTION— 510(k) K033470

Clearance details

Applicant

Nucletron Corporation

Product code

Code KPQ

Device class

Class 2

Regulation

21 CFR 892.5840

Advisory panel

Radiology

Date received

2003-11-03

Decision date

2004-02-04

Decision

Substantially Equivalent

Clearance type

Special

Location

Columbia, MD, US

• K132944 — ADVANTAGESIM MD MR PELVIC ORGAN AT RISK SEGMENTATION2014-03-14
• K132045 — ADVANTAGESIM MD WITH CT ATLAS-BASED CONTOURING AND RE-PLANNING OPTIONS2013-09-04
• K101038 — RAD II SIMULATOR, RAD II KV IMAGER, DUAL RAD II KV IMAGER2010-08-17
• K090706 — ONCENTRA SIMULATION 2.32009-06-15
• K083591 — IKOENGELO, VERSION 22008-12-29

• K103515 — EQUAL DOSE2011-09-15
• K091154 — UTRECHT INTERSTITIAL FLETCHER CT/MR APPLICATOR SET, MODEL 110.270, INTERSTITIAL RING CT/MR APPLICATOR SET,MODEL 110.330,2009-05-18
• K082642 — ONCENTRA RT VIEWER 1.02008-11-07
• K080934 — VIENNA RING CT/MR APPLICATOR SET, ROUND POINT TITANIUM NEEDLE SET, TROCAR POINT TITANIUM NEEDLE SET2008-05-28
• K081281 — OCENTRA MASTERPLAN 3.1 (OCENTRA BRACHY)2008-05-20