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Panels › Radiology › Product code MUJ · Class 2

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)
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Top companies in MUJ

Company510(k)sRecalls
Raysearch Laboratories AB7117
Elekta, Inc.246
Computerized Medical Systems, Inc.931
Varian Medical Systems337
Siemens Medical Solutions USA, Inc.136
Brainlab AG117
Varian Medical Systems, Oncology Systems117
Accuray Incorporated96
RaySearch Laboratories AB (PUBL)150
Nucletron131
DateFirm and productCodeLinked 510(k)
Feb 20, 2020RAYSEARCH LABORATORIES AB
RayStation/RayPlan 8B Service Pack 2, Build Number 8.1.2.5, stand-alone software treatment planning system
Terminated		 MUJK190387
Feb 20, 2020RAYSEARCH LABORATORIES AB
RayStation/RayPlan 8B Service Pack 1, Build Number 8.1.1.8, stand-alone software treatment planning system
Terminated		 MUJK190387
Feb 20, 2020RAYSEARCH LABORATORIES AB
RayStation/RayPlan 8B, Build Number 8.1.0.47, stand-alone software treatment planning system
Terminated		 MUJK190387
Feb 20, 2020RAYSEARCH LABORATORIES AB
RayStation/RayPlan 8A Service Pack 1, Build Number 8.0.1.10, stand-alone software treatment planning system
Terminated		 MUJK190387
Feb 20, 2020RAYSEARCH LABORATORIES AB
RayStation/RayPlan 8A, Build Number 8.0.0.61, stand-alone software treatment planning system
Terminated		 MUJK190387
Jan 27, 2020RAYSEARCH LABORATORIES AB
RayStation stand-alone software treatment planning system. Models 4.0, 4.3, 4.5, 4.7, 4.9, 5.0, 6.0, 6.1, 6.2, 6.3, 7.0, 8.0, 8.1, 9.0.
Terminated		 MUJK190387
Nov 22, 2019Elekta Inc
Monaco Radiation Treatment Planning System (RTP) System
Open, Classified		 MUJK183037
K190178
Nov 18, 2019RAYSEARCH LABORATORIES AB
RayStation stand-alone software treatment planning system, Model Numbers 4.0, 4.5, 4.7, 4.9, 5.0, 6.0, 6.1, 6.2, 6.3, 7.0, 8.0, 8.1, 9.0 - Product Usage: RayStation is a software system designed for t
Terminated		 MUJK190387
Sep 4, 2019Elekta Inc
Monaco RTP System, 5.50/5.51, radiation treatment planning system Product Usage: The Monaco system is used to make treatment plans for patients with prescriptions for external beam radiation therapy.
Open, Classified		 MUJK190178
Sep 4, 2019Elekta Inc
Monaco RTP System, 5.40 Unity, radiation treatment planning system Product Usage: The Monaco system is used to make treatment plans for patients with prescriptions for external beam radiation therapy
Open, Classified		 MUJK183037
Aug 23, 2019Elekta, Inc.
Monaco Radiation Treatment Planning System (RTP) System
Terminated		 MUJK190178
Jul 3, 2019Elekta Inc
Monaco RTP System, software versions 5.10 and 5.11, Radiation Treatment Planning System
Open, Classified		 MUJK151233
Mar 11, 2019Brainlab AG
RT Elements Software revisions of the RT Elements applications have a specific software version number. Specifically the following RT Elements applications/versions are affected: - Cranial SRS 1.0.0
Terminated		 MUJK142108
K170750
Feb 8, 2019Elekta, Inc.
Monaco Radiation Treatment Planning (RTP) System
Terminated		 MUJK183037
Dec 26, 2018Varian Medical Systems, Inc.
Eclipse(TM) Treatment Planning System with Proton Convolution Superposition algorithm license only The Eclipse Treatment Planning System (Eclipse TPS) is used to plan radiotherapy treatments for pati
Terminated		 MUJK170969
K172163 +1
Nov 12, 2018RAYSEARCH LABORATORIES AB
RayStation 3.5, RayStation 4.0, RayStation 4.5, RayStation 4.7, RayStation 5, RayStation 6, RayStation 7 and RayStation 8A
Terminated		 MUJK180379
Sep 21, 2018RAYSEARCH LABORATORIES AB
RayStation 4.5, RayStation 4.7, RayStation 5, RayStation 6 and RayStation 7, a stand-alone software treatment planning system.
Terminated		 MUJK180379
Jun 29, 2018RAYSEARCH LABORATORIES AB
RayStation stand-alone software treatment planning system, RayStation 4.5, RayStation 4.7, RayStation 4.9 (RayPlan 1), RayStation 5, RayStation 6 (RayPlan 2), RayStation 7 (RayPlan 7) and RayStation
Terminated		 MUJK180379
Jun 6, 2018RAYSEARCH LABORATORIES AB
RayStation Radiation Therapy Treatment Planning System, Model nos. 2.5, 3.5, 4.0, 4.3, 4.5, 4.7, 4.9, 5.0, 6.0, 6.1, 6.2, 7.0 Product Usage RayStation is a software system designed for treatment plan
Terminated		 MUJK180379
Mar 28, 2018RAYSEARCH LABORATORIES AB
RayStation Radiation Therapy Treatment Planning System; 6.0, 6.1, 6.2, 7.0 Product Usage: Usage: RayStation is a software system designed for treatment planning and analysis of radiation therapy. Th
Terminated		 MUJK171536
Jan 26, 2018RAYSEARCH LABORATORIES AB
Ray Station 4.9 Ray Station 5, Ray Station 6 and Ray Station 7 Software build numbers: 4.9.0.42, 5.0.0.37, 5.0.1.11, 5.0.2.35, 6.0.0.24, 6.1.0.26, 6.1.1.2, 6.2.0.7 or 7.0.0.19 UDI: 0735000201006820171
Terminated		 MUJK171536
Nov 20, 2017RAYSEARCH LABORATORIES AB
RayStation 3.5, RayStation 4.0, RayStation 4.5, RayStation 4.7, RayStation 5, RayStation 6, RayPlan 1 (RayStation 4.9) and RayPlan 2 (RayStation 6) . Intended Use: software system designed for treatme
Terminated		 MUJK171536
Sep 1, 2017Elekta Inc
Elekta ERGO++ Product Usage: ERGO is often used for stereotactic treatments.
Terminated		 MUJK080601
Aug 10, 2017Nucletron BV
Oncentra Brachy 4.5 radiation therapy software The firm name on the label is Nucletron B.V. Oncentra is a radiation therapy planning software designed to analyze and plan radiation treatments in t
Terminated		 MUJK132816
Jul 17, 2017RAYSEARCH LABORATORIES AB
RayStation Product Usage: is a software system designed for treatment planning and analysis of radiation therapy. The treatment plans provide treatment unit set-up parameters and estimates of dose
Terminated		 MUJK171536
Jan 18, 2017RAYSEARCH LABORATORIES AB
Radiation Therapy Treatment Planning System, Model 4.5, 4.7, 5.0 RayStation is a software system designed for treatment planning and analysis of radiation therapy. The treatment plans provide treatmen
Terminated		 MUJK160093
Jan 10, 2017Elekta, Inc.
Monaco RTP System. Used to make treatment plans for patients with prescriptions for external beam radiation therapy.
Terminated		 MUJK151233
Dec 23, 2016Elekta, Inc.
Oncentra External Beam Oncentra Brachy Product Usage: Oncentra is radiation therapy planning software designed to analyze and plan radiation treatment is three dimensions for the purpose of treating
Terminated		 MUJK121448
Dec 21, 2016Elekta, Inc.
Monaco RTP System Product Usage: Used to make treatment plans for patients with prescriptions for external beam radiation therapy.
Terminated		 MUJK132971
K151233
Nov 17, 2016Elekta, Inc.
Monaco TRP System The Monaco system is used to make treatment plans for patients with prescriptions for external beam radiation therapy.
Terminated		 MUJK132971
Nov 15, 2016Mevion Medical Systems, Inc.
MEVION S250 Product Usage: Proton Radiation Therapy System
Terminated		 MUJK120676
Nov 15, 2016Mevion Medical Systems, Inc.
MEVION S250 Product Usage: Proton Radiation Therapy
Terminated		 MUJK120676
Nov 15, 2016Mevion Medical Systems, Inc.
MEVION S250 Product Usage: Proton Radiation Therapy System
Terminated		 MUJK120676
Nov 9, 2016RAYSEARCH LABORATORIES AB
RayStation 4.0, 4.5, 4.7 and 5.0; Radiation Therapy Treatment Planning System Product Usage: RayStation is a software system designed for treatment planning and analysis of radiation therapy. The tre
Terminated		 MUJK160093
Nov 3, 2016Elekta, Inc.
Monaco RTP System; Used to make treatment plans for patients with prescriptions for external beam radiation therapy.
Terminated		 MUJK151233
Oct 11, 2016RAYSEARCH LABORATORIES AB
Radiation Therapy Treatment Planning System Product Usage: RayStation is a software system designed for treatment planning and analysis of radiation therapy. The treatment plans provide treatment un
Terminated		 MUJK160093
Sep 29, 2016Elekta, Inc.
Monaco RTP System The Monaco system is used to make treatment plans for patients with prescriptions for external beam radiation therapy. The system calculates dose for photon treatment plans and displ
Terminated		 MUJK151233
Sep 1, 2016RAYSEARCH LABORATORIES AB
RayStation 2.5, 3.0, 3.5, 4.0, 4.5, 4.7, 5.0 and 4.3 (InverseArc 1.0) -- Radiation Therapy Treatment Planning System RayStation is a software system designed for treatment planning and analysis of rad
Terminated		 MUJK160093
Aug 18, 2016Elekta, Inc.
Monaco RTP System Used to make treatment plans for patients with prescriptions for external beam radiation therapy.
Terminated		 MUJK110730
Jul 1, 2016RAYSEARCH LABORATORIES AB
RayStation 3.0, RayStation 3.5, RayStation 4.0, RayStation 4.5, RayStation 4.7 and RayStation 5 --- Radiation Therapy Treatment Planning System --- designed for treatment planning and analysis of radi
Terminated		 MUJK160093
May 30, 2016RAYSEARCH LABORATORIES AB
Radiation Therapy Treatment Planning System, Model 5.0
Terminated		 MUJK160093
May 25, 2016RAYSEARCH LABORATORIES AB
RayStation Therapy Treatment Planning System Stand-alone Software 3.0, 3.5, 4.0, 4.5 and 4.7., designed for treatment planning and analysis of radiation therapy.
Terminated		 MUJK141860
May 18, 2016Elekta, Inc.
Monaco RTP System Product Usage: The Monaco system is used to make treatment plans for patients with prescriptions for external beam radiation therapy.
Terminated		 MUJK151233
Feb 12, 2016Varian Medical Systems, Inc.
Eclipse Treatment Planning System versions 11, 13.0, 13.5 and 13.6; Model number: H48; Product Usage: The Eclipse Treatment Planning System (Eclipse TPS) is used to plan radiotherapy treatments for
Terminated		 MUJK152393
Dec 18, 2015Elekta, Inc.
Oncentra External Beam - VMAT - Radiation therapy planning system Product Usage: The Oncentra system is a radiation treatment planning software designed to analyze and plan radiation treatments in t
Terminated		 MUJK121448
Nov 5, 2015Brainlab AG
RT Elements are applications for radiation treatment planning for use in stereotactic, conformal, computer planned, Linac based radiation treatment of cranial, head and neck, and extracranial lesions.
Terminated		 MUJK142108
Nov 5, 2015Brainlab AG
RT Elements are applications for radiation treatment planning for use in stereotactic, conformal, computer planned, Linac based radiation treatment of cranial, head and neck, and extracranial lesions.
Terminated		 MUJK142108
Oct 30, 2015Elekta, Inc.
Monaco - Radiation Treatment Planning used to make treatment plans for patients with prescriptions for external beam radiation therapy.
Terminated		 MUJK151233
Oct 30, 2015Varian Medical Systems, Inc.
ARIA Radiation Oncology, versions 10, 11 , 13.0 and 13.5 with Clinical Assessment License. Model number HIT Product Usage: ARIA Radiation Oncology is a radiation treatment plan and image managemen
Terminated		 MUJK093527
Oct 7, 2015Elekta, Inc.
Monaco Radiation Treatment Planning System. Used to make treatment plans for patients with prescriptions for external beam radiation therapy.
Terminated		 MUJK151233

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