FDA Product Code MUJ: System, Planning, Radiation Therapy Treatment
Precision in radiation therapy begins before the first beam is delivered. FDA product code MUJ covers radiation therapy treatment planning systems.
These software platforms import patient imaging data, define target volumes and critical structures, and calculate optimized dose distributions for external beam and brachytherapy treatments. They are the computational backbone of modern radiotherapy and work in conjunction with linear accelerators and brachytherapy systems.
MUJ devices are Class II medical devices, regulated under 21 CFR 892.5050 and reviewed by the FDA Radiology panel.
Leading manufacturers include Varian Medical Systems, Inc., RaySearch Laboratories AB (PUBL) and Siemens Medical Solutions USA, Inc..
257
Total
257
Cleared
117d
Avg days
1995
Since
257 devices
Cleared
Sep 18, 2015
Eclipse Treatment Planning System
Varian Medical Systems, Inc.
Radiology
25d
Cleared
Sep 16, 2015
syngo VSim
Siemens Medical Solutions USA, Inc.
Radiology
68d
Cleared
Sep 11, 2015
QuickPlan
Siris Medical
Radiology
93d
Cleared
Sep 03, 2015
Leksell GammaPlan
Elekta Instrument AB
Radiology
76d
Cleared
Aug 13, 2015
syngo.via RT Image Suite
Siemens Medical Solutions USA, Inc.
Radiology
83d
Cleared
Aug 07, 2015
.decimal p.d
.Decimal, LLC
Radiology
78d
Cleared
Jul 07, 2015
Monaco
Impac Medical Systems, Inc.
Radiology
60d
Cleared
May 20, 2015
SAGIPLAN, SAGIPLAN PROSTATE MODULE ADD ON, SAGIPLAN INCLUDING PROSTATE MODULE
Eckert & Ziegler Bebig GmbH
Radiology
310d
Cleared
May 15, 2015
.decimal Astroid Dosimetry App
.Decimal, Inc.
Radiology
73d
Cleared
Apr 14, 2015
Delivery Analysis
Accuray Incorporated
Radiology
152d
Cleared
Dec 16, 2014
RT ELEMENTS, DOSE REVIEW, BRAIN METASTASES, ADAPTIVE HYBRID SURGERY ANALYSIS
Brainlab AG
Radiology
134d
Cleared
Oct 23, 2014
RAYSTATION
Raysearch Laboratories AB
Radiology
105d
Cleared
Sep 05, 2014
SMART SEGMENTATION KNOWLEDGE BASED CONTOURING
Varian Medical Systems, Inc.
Radiology
114d
Cleared
Aug 07, 2014
ECLIPSE TREATMENT PLANNING SYSTEM
Varian Medical Systems, Inc.
Radiology
83d
Cleared
Jun 13, 2014
ONCENTRA BRACHY
Nucletron B.V.
Radiology
277d
Cleared
May 15, 2014
RAY STATION
Raysearch Laboratories AB
Radiology
111d
Cleared
Feb 07, 2014
ECLIPSE TREATMENT PLANNING SYSTEM
Varian Medical Systems, Inc.
Radiology
108d
Cleared
Jan 31, 2014
RADIANCE V2
Gmv Soluciones Globales Internet S.A.U.
Radiology
65d
Cleared
Jan 27, 2014
4D INTEGRATED TREATMENT CONSOLE
Varian Medical Systems, Inc.
Radiology
90d
Cleared
Nov 20, 2013
MONACO
Impac Medical Systems, Inc.
Radiology
58d
Cleared
Sep 25, 2013
ECLIPSE TREATMENT PLANNING SYSTEM
Varian Medical Systems, Inc.
Radiology
92d
Cleared
Jul 16, 2013
RADVISION
Acoustic Medsystems, Inc.
Radiology
60d
Cleared
May 10, 2013
RAYSTATION
Raysearch Laboratories AB
Radiology
64d
Cleared
Apr 04, 2013
HDRPLUS, ADD IN PROSTATE MODULE FOR HDRPLUS
Eckert & Ziegler Bebig GmbH
Radiology
168d