System, Planning, Radiation Therapy Treatment
Regulation 892.5050
13510(k)s in 12 months (258 all time)
13recalls in 12 months (270 all time)
257recalls that name a 510(k)
Top companies in MUJ
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 17, 2015 | RAYSEARCH LABORATORIES AB Radiation Therapy Treatment Planning System software
RayStation is a software system designed for treatment planning and analysis of radiation therapy. The treatment plans provide treatment unit set- Terminated |
MUJ | K141860 |
| Aug 31, 2015 | Elekta, Inc. XiO Radiation Treatment Planning System.
Used to create treatment plans for any cancer patient for whom external beam radiation therapy or brachytherapy has been prescribed. Terminated |
MUJ | K102216 |
| Aug 25, 2015 | RAYSEARCH LABORATORIES AB RayStation 4.7, version 4.7.1, used with Structure Definition or Automatic Breast Planning. Radiation Therapy Treatment Planning System, for treatment planning and analysis of radiation therapy. Terminated |
MUJ | K141860 |
| Jun 4, 2015 | Elekta, Inc. Oncentra Brachy radiation therapy planning software designed to analyze and plan radiation treatments in three dimensions for the purpose of treating patients with cancer. Terminated |
MUJ | K081281 K121448 |
| May 27, 2015 | RAYSEARCH LABORATORIES AB RaySearch RayStation 2.5, 3.0, 3.5 and 4.0; Radiation Therapy Treatment
Product Usage:
RayStation is a software system designed for treatment planning and analysis of radiation therapy. The treatmen Terminated |
MUJ | K120387 K130617 +1 |
| May 21, 2015 | Philips Medical Systems, Inc. Pinnacle3 Software Version 10.0, Model 459800200841.
Product Usage:
The Pinnacle 3 RTP software allows qualified medical professionals to enter patient data into the system, use that data to constru Terminated |
MUJ | K041577 |
| Mar 20, 2015 | RAYSEARCH LABORATORIES AB RayStation Radiation Therapy Treatment Planning System; -- RayStation 3.5, RayStation 4.0, RayStation 4.5 and RayStation 4.7. For RayStation 4.7, the issue applies also to machines with fixed jaws, r Terminated |
MUJ | K141860 |
| Mar 4, 2015 | Elekta, Inc. Focal Sim radiation therapy treatment planning system Terminated |
MUJ | K013112 |
| Mar 2, 2015 | Elekta, Inc. Monaco radiation therapy treatment planning system.
The Monaco system is used to make treatment plans for patients with prescriptions for external beam radiation therapy. The system calculates dos Terminated |
MUJ | K132971 |
| Jan 15, 2015 | Brainlab AG iPlan RT is a radiation treatment planning system that is intended for use in stereotactic, conformal, computer planned, Linac based radiation treatment of cranial, head and neck, and extracranial les Terminated |
MUJ | K053584 K080888 +1 |
| Jan 15, 2015 | Brainlab AG iPlan RT Dose is a stereotactic radiation treatment planning system that is intended for use in stereotactic, conformal, computer planned, Linac based radiation treatment of cranial, head and neck, an Terminated |
MUJ | K053584 K080888 +1 |
| Sep 16, 2014 | Varian Medical Systems, Inc. 4D Integrated Treatment Console (4DITC), versions 10 and 11.
4DITC provided assistance for accurate treatment delivery by monitoring linear accelerator parameters and preventing the radiation thera Terminated |
MUJ | K133331 |
| Sep 4, 2014 | Elekta, Inc. Monaco
The Monaco system is used to make treatment plans for patients with prescriptions for external beam radiation therapy. The system calculates dose for photon and electron treatment plans and d Terminated |
MUJ | K132971 |
| Sep 3, 2014 | Elekta, Inc. FOCAL Sim Workstation, Radiation Treatment Planning System.
Used for patient contouring and viewing of treatment plan outputs. Also able to perform CT simulations and forward their information to t Terminated |
MUJ | K013112 |
| Jul 17, 2014 | Siemens Medical Solutions USA, Inc Siemens syngo RT Dosimetrist 2.7 system
Product Usage: The intended use of syngo Suite for Oncology Systems is as an accessory to the linear accelerator system to aid and support in the planning and Terminated |
MUJ | K101119 |
| Jun 17, 2014 | RAYSEARCH LABORATORIES AB RayStation software version 4.0.3.4
RayStation is a software system designed for treatment planning and analysis of radiation therapy. Terminated |
MUJ | K130617 |
| Apr 21, 2014 | RAYSEARCH LABORATORIES AB RaySearch Ray Station Radiation Therapy Treatment Planning System, Stand-alone software. Versions 2.0, 2.5, 3.0, 3.5 and 4.0. Terminated |
MUJ | K100552 K120387 +1 |
| Mar 31, 2014 | Philips Medical Systems (Cleveland), Inc. Pinnacle3 Radiation Therapy Planning (RTP) System, software version 9.0. Terminated |
MUJ | K041577 |
| Mar 31, 2014 | RAYSEARCH LABORATORIES AB RaySearch Ray Station, Radiation Therapy Treatment Planning System, Stand-alone software Terminated |
MUJ | K130617 |
| Mar 28, 2014 | RAYSEARCH LABORATORIES AB RayStation Radiation Therapy Treatment Planning System, models 2.5, 3.0, 3.5 and 4.0; a software system designed for treatment planning and analysis of radiation therapy. Terminated |
MUJ | K100552 K120387 +1 |
| Mar 13, 2014 | Elekta, Inc. XiO RPT System
The XiO RTP System is used to create treatment plans for any cancer patient for whom external beam radiation therapy or brachytherapy has been prescribed. The system will calculate and Terminated |
MUJ | K102216 |
| Feb 4, 2014 | Elekta, Inc. XiO RTP System.
Used to create treatment plans for any cancer patient for whom external beam radiation therapy or brachytherapy has been prescribed. Terminated |
MUJ | K102216 |
| Jan 17, 2014 | Elekta, Inc. XiO RTP System
The XiO RTP System is used to create treatment plans for any cancer patient for whom external beam radiation therapy or brachytherapy has been prescribed. The system will calculate and Terminated |
MUJ | K102216 |
| Dec 20, 2013 | Varian Medical Systems, Inc. Plan Parameters workspace within
Eclipse Treatment Planning System Version 11 and 13;
ARIA Radiation Oncology versions 11 and 13
Acuity, versions 11 and 13.
Manufactured by Varian Medical Systems
Pal Terminated |
MUJ | K093527 K131807 |
| Nov 14, 2013 | RAYSEARCH LABORATORIES AB Ray Station Radiation Therapy Treatment Planning System, Model Numbers 3.0, 3.5 and 4.0 Terminated |
MUJ | K120387 K130617 |
| Sep 25, 2013 | Elekta, Inc. Monaco RTP System Radiation Therapy Treatment Planning System.
Radiation treatment planning. Terminated |
MUJ | K110730 |
| Sep 25, 2013 | Elekta, Inc. Monaco RTP System
Radiation treatment planning Terminated |
MUJ | K110730 |
| May 28, 2013 | RAYSEARCH LABORATORIES AB RayStation Therapy Treatment Planning System, Model Numbers 2.0, 2.5, and 3.0; CLASSIFICATION NAME: System, Planning, Radiation Therapy Treatment.
RayStation is a software system designed for treatme Terminated |
MUJ | K120387 |
| Apr 12, 2013 | Integra LifeSciences Corp. Integra XKnife Stereotactic Radiosurgery and Radiotherapy Treatment Planning,
Software Versions 5.0.1 and 5.0.2.
Intended for use in stereotactic and non-stereotactic (frameless stereotactic), collim Terminated |
MUJ | K100417 |
| Feb 20, 2013 | Elekta, Inc. Monaco RTP System.
Radiation treatment planning. Terminated |
MUJ | K110730 |
| Feb 20, 2013 | Varian Medical Systems, Inc. Oncology Systems Varian Eclipse Treatment Planning System for Radiotherapy; Model Number: H48. In addition, the Eclipse Proton Eye algorithm is specifically indicated for planning proton treatment of neoplasms of the Terminated |
MUJ | K102011 |
| Oct 23, 2012 | Elekta, Inc. Oncentra External Beam 4.1.
Radiation treatment planning software designed to analyze and plan radiation treatments in their dimension for the purpose of treating patients with cancer. Terminated |
MUJ | K081281 |
| Sep 26, 2012 | Varian Medical Systems, Inc. Oncology Systems Varian brand Eclipse Treatment Planning System, Model Number: H48; Eclipse 8.9 and 10.0
Reference/FSCA Identifier: CP-08922; Product is manufactured and distributed by Varian Medical Systems Inc., Pal Terminated |
MUJ | K102011 |
| Sep 24, 2012 | RAYSEARCH LABORATORIES AB SharePlan 1.1, aka t-RayAutoplan version 1.2.1 (build number 1.3.1.10). Manufacturing name RayAutoplan, aka t-RayAutoplan, commercial name (TomoTherapy) SharePlan
Intended use: t-RayAutoplan is a so Terminated |
MUJ | K083264 |
| Sep 14, 2012 | RAYSEARCH LABORATORIES AB The product affected by this notice is sold under the trade name TomoTherapy SharePlan 1.1. To determine if the version you are using is affected, bring up the About box in the SharePlan application a Terminated |
MUJ | K083264 |
| Sep 6, 2012 | RAYSEARCH LABORATORIES AB Brand name: RayStation. Generic name: Treatment Planning System. Software version and build numbers are 2.5.0.144 and 2.5.1.89. Product lifetime is 5 years.
RayStation is a software system design Terminated |
MUJ | K120387 |
| Jul 19, 2012 | Varian Medical Systems, Inc. Oncology Systems Varian brand Varian Eclipse Treatment Planning System for radiotherapy; Model Number: H48; Product is manufactured and distributed by Varian Medical Systems Inc., Palo Alto, CA
The Eclipse Treatmen Terminated |
MUJ | None listed |
| Jul 12, 2012 | Elekta, Inc. Monaco
Product Usage:
Planning of radiation therapy Terminated |
MUJ | K110730 |
| Jul 12, 2012 | Elekta, Inc. Focal SIM
Planning of radiation therapy Terminated |
MUJ | K013112 |
| May 22, 2012 | Computerized Medical Systems Inc XiO Radiation Treatment Planning System, Versions 4.30.00-4.64.00.
Used to create treatment plans for any cancer patient for whom external beam radiation therapy or brachytherapy has been prescribed. Terminated |
MUJ | K102216 |
| Apr 3, 2012 | Computerized Medical Systems Inc Monaco Radiation Treatment Planning System, Version 3.10.00.
Planning of radiation therapy. Terminated |
MUJ | K110730 |
| Mar 26, 2012 | RAYSEARCH LABORATORIES AB RayStation Version 2.0.0.15, Radiation Therapy Treatment Planning System.
RaySearch Laboratories AB Sveavagen 25, SE-111 34 Stockholm Sweden. support@raysearchlabs.com
Designed for treatment plann Terminated |
MUJ | K100552 |
| Mar 6, 2012 | Varian Medical Systems, Inc. Oncology Systems Eclipse Treatment Planning System, versions 7.3, 8.0, 8.1, 8.2, 8.6, 8.9 and 10.0;
Model H48
Varian Medical Systems, Palo Alto, CA.
Product Usage:
The Eclipse Treatment Planning System (Eclipse TPS) Terminated |
MUJ | K102011 |
| Jan 13, 2012 | Varian Medical Systems, Inc. Oncology Systems Varian brand Eclipse Treatment Planning System, 7.3, 8.0, 8.1, 8.2, 8.6, 8.9, 10.0; Model Number: H48;
Reference/FSCA Identifier: CP-07007, Product is manufactured and distributed by Varian Medical S Terminated |
MUJ | K102011 |
| Jan 11, 2012 | Varian Medical Systems, Inc. Oncology Systems Varian brand Eclipse Release 10 with RT Chart Release 10 (Client Build 10.0.28 or Build 10.0.34), An
Eclipse Treatment Planning System used with ARIA Radiation Oncology (RT Chart
module), Reference/F Terminated |
MUJ | K091492 |
| Dec 2, 2011 | RAYSEARCH LABORATORIES AB RayStation Version 2.0.0.15 Consult instruction for use. RaySearch Laboratories AB Sveavagen 25, SE-111 34 Stockholm Sweden. support@raysearchlabs.com
RayStation is a software system designed for Terminated |
MUJ | K100552 |
| Dec 1, 2011 | PerMedics, Inc. Odyssey
A radiation treatment planning system Terminated |
MUJ | K042861 |
| Aug 31, 2011 | Accuray Incorporated HiArt versions 4.0.x, and HD versions 1.0.x, H-0000-0003.
The TomoTherapy HI-ART System is intended to be used as an integrated system for the planning and precise delivery of radiation therapy, ster Terminated |
MUJ | K082005 |
| Aug 31, 2011 | Varian Medical Systems, Inc. BrachyVision, versions 8.2, 8.5, 8.6 and 8.9.
Varian Medical Systems.
3100 Hansen Way,
Palo Alto, California 94304-1038.
Used to plan radiotherapy treatments for patients with malignant or benign d Terminated |
MUJ | K091492 |
| Aug 15, 2011 | Varian Medical Systems, Inc. Oncology Systems Eclipse Treatment Planning System, 4D Structure Merge Tool Option in Eclipse Release 8.5 -10 (Client Build 8.2.2x through 10.0.34) with 4D Planning; Model Number: H48;
Reference/FSCA Identifier: CP- Terminated |
MUJ | K073020 |
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