MUJ · Class II · 21 CFR 892.5050

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
97–120 of 257
Cleared Sep 18, 2015
Eclipse Treatment Planning System
K152393
Varian Medical Systems, Inc.
Radiology · 25d
Cleared Sep 16, 2015
syngo VSim
K151887
Siemens Medical Solutions USA, Inc.
Radiology · 68d
Cleared Sep 11, 2015
QuickPlan
K151560
Siris Medical
Radiology · 93d
Cleared Sep 03, 2015
Leksell GammaPlan
K151666
Elekta Instrument AB
Radiology · 76d
Cleared Aug 13, 2015
syngo.via RT Image Suite
K151380
Siemens Medical Solutions USA, Inc.
Radiology · 83d
Cleared Aug 07, 2015
.decimal p.d
K151369
.Decimal, LLC
Radiology · 78d
Cleared Jul 07, 2015
Monaco
K151233
Impac Medical Systems, Inc.
Radiology · 60d
Cleared May 20, 2015
SAGIPLAN, SAGIPLAN PROSTATE MODULE ADD ON, SAGIPLAN INCLUDING PROSTATE MODULE
K141900
Eckert & Ziegler Bebig GmbH
Radiology · 310d
Cleared May 15, 2015
.decimal Astroid Dosimetry App
K150547
.Decimal, Inc.
Radiology · 73d
Cleared Apr 14, 2015
Delivery Analysis
K143269
Accuray Incorporated
Radiology · 152d
Cleared Dec 16, 2014
RT ELEMENTS, DOSE REVIEW, BRAIN METASTASES, ADAPTIVE HYBRID SURGERY ANALYSIS
K142108
Brainlab AG
Radiology · 134d
Cleared Oct 23, 2014
RAYSTATION
K141860
Raysearch Laboratories AB
Radiology · 105d
Cleared Sep 05, 2014
SMART SEGMENTATION KNOWLEDGE BASED CONTOURING
K141248
Varian Medical Systems, Inc.
Radiology · 114d
Cleared Aug 07, 2014
ECLIPSE TREATMENT PLANNING SYSTEM
K141283
Varian Medical Systems, Inc.
Radiology · 83d
Cleared Jun 13, 2014
ONCENTRA BRACHY
K132816
Nucletron B.V.
Radiology · 277d
Cleared May 15, 2014
RAY STATION
K140187
Raysearch Laboratories AB
Radiology · 111d
Cleared Feb 07, 2014
ECLIPSE TREATMENT PLANNING SYSTEM
K133247
Varian Medical Systems, Inc.
Radiology · 108d
Cleared Jan 31, 2014
RADIANCE V2
K133655
Gmv Soluciones Globales Internet S.A.U.
Radiology · 65d
Cleared Jan 27, 2014
4D INTEGRATED TREATMENT CONSOLE
K133331
Varian Medical Systems, Inc.
Radiology · 90d
Cleared Nov 20, 2013
MONACO
K132971
Impac Medical Systems, Inc.
Radiology · 58d
Cleared Sep 25, 2013
ECLIPSE TREATMENT PLANNING SYSTEM
K131891
Varian Medical Systems, Inc.
Radiology · 92d
Cleared Jul 16, 2013
RADVISION
K131428
Acoustic Medsystems, Inc.
Radiology · 60d
Cleared May 10, 2013
RAYSTATION
K130617
Raysearch Laboratories AB
Radiology · 64d
Cleared Apr 04, 2013
HDRPLUS, ADD IN PROSTATE MODULE FOR HDRPLUS
K123263
Eckert & Ziegler Bebig GmbH
Radiology · 168d