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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

DateFirm and productCodeLinked 510(k)
Aug 25, 2023RAYSEARCH LABORATORIES AB
RayCare software, include version number 5A, 5B, 6A, including service packs-An oncology information system used to support workflows and scheduling, as well as clinical information, planning and trea
Open, Classified
MUJK200487
Jun 29, 2023RaySearch America Inc
Radiation therapy software, RayStation standalone software treatment planning system. Model numbers: 8B, 8B SP1, 8B SP2, 9A, 9B, 9B SP1, 10A, 10A SP1 and 10B. Software versions: 8.1, 9.0, 9.1, 9.2, 10
Terminated
MUJK200569
Mar 22, 2023RAYSEARCH LABORATORIES AB
Raystation treatment planning system for radiation therapy, Model Numbers 9.0.0, 9.0.1, 9.1.0, 9.2.0, 10.0.0, 10.0.1, 10.0.2, 10.1.0, 10.1.1, 11.0.0, 11.0.1, 11.0.3, 11.0.4, 12.0.0, 12.1.0, 12.1.1, 12
Open, Classified
MUJK190387
Mar 8, 2023Elekta Inc
Monaco RTP System. Used to make treatment plans for patients with prescriptions for external beam radiation therapy.
Open, Classified
MUJK151233
Dec 15, 2022Elekta, Inc.
Oncentra Brachy radiation therapy planning system software.
Open, Classified
MUJK132816
Sep 15, 2022Philips Medical Systems (Cleveland) Inc
Pinnacle3 Radiation Therapy Planning System, Model numbers 870231 and 870237.
Open, Classified
MUJK170086
Jun 10, 2022RAYSEARCH LABORATORIES AB
RayStation 11B
Terminated
MUJK220141
Jun 1, 2022RAYSEARCH LABORATORIES AB
RayStation 9B SP1. For radiation treatment planning.
Terminated
MUJK200569
Mar 7, 2022Siemens Medical Solutions USA, Inc
syngo.via RT Image Suite upgraded to VB60 running on syngo.via Model Number 10496180. Running on servers with syngo.via VB60 software after upgrade and CT scanners with syngo.CT VA40A after upgrade.
Terminated
MUJK211379
Feb 11, 2022RaySearch America Inc
RayStation 4-11B, and RayPlan 1, 2, 7-11B including some service packs: RayStation 4.0 (4.0.0.14) to RayStation 5 Service Pack 2 (5.0.2.35), RayStation 5 Service Pack 3 (5.0.3.17), RayStation 6/Ray
Open, Classified
MUJK211867
Dec 30, 2021RAYSEARCH LABORATORIES AB
RayStation/RayPlan- designed for treatment planning and analysis of radiation therapy. Software Version: 6.0.0.24 , 6.1.0.26 , 6.1.1.2 , 6.2.0.7 , 6.3.0.6 , 7.0.0.19 , 8.0.0.61 , 8.0.1.10 , 8
Open, Classified
MUJK211867
Oct 13, 2021Elekta, Inc.
Oncentra Brachy users using version 4.0 and above with Applicator Modeling license 170283-00
Open, Classified
MUJK132816
Sep 22, 2021RAYSEARCH LABORATORIES AB
RayStation/RayPlan versions 4 - 11A, including service packs. Build Stations: 4.0.0.14, 4.0.3.4, 4.3.0.14, 4.5.1.14, 4.7.2.5, 4.7.3.13, 4.7.4.4, 4.7.5.4, 4.7.6.7, 4.9.0.42, 5.0.1.11, 5.0.2.35, 5.0.3.1
Open, Classified
MUJK211867
Sep 14, 2021Elekta Inc
Elekta Monaco - Product Usage: used to make treatment plans for patients with prescriptions for external beam radiation therapy.
Open, Classified
MUJK183037
K190178
Sep 10, 2021Siemens Medical Solutions USA, Inc
syngo.via RT Image Suite with syngo.via VB30, VB40, VB50 and VB60- Intended for Radiation Therapy Treatment Material Number: 10496180
Open, Classified
MUJK211379
Sep 9, 2021RAYSEARCH LABORATORIES AB
TomoHelical and TomoDirect plans in RayStation 6, 7, 8A, 8B, 9A, 9B, 10A, 10B and 11A. Build Numbers: 6.1.1.2, 6.2.0.7, 6.3.0.6, 7.0.0.19, 8.0.0.61, 8.0.1.10, 8.1.0.47, 8.1.1.8, 8.1.2.5, 9.0.0.113, 9.
Terminated
MUJK210645
Jul 26, 2021Elekta Inc
Monaco RTP System, Software Builds 5.40.00, 5.40.01, 5.40.02, and 5.51.10
Open, Classified
MUJK183037
K190178
Jun 8, 2021RAYSEARCH LABORATORIES AB
RayStation (Radiation Treatment Planning System) : RayStation 9A, 9B, 9B SP1, 10A, 10A SP1, 10B and 11A, in combination with RayCare Model Numbers/ UDI: RayStation 9.0 (9.0.0.113) 07350002010174; Ra
Terminated
MUJK200487
K200569
May 4, 2021Viewray, Inc.
ViewRay MRIdian Linac System: Model No. 20000-01 software, CE 0086 - Product Usage: intended to be used for planning external beam irradiation with photon beams and delivering stereotactic radiosurge
Terminated
MUJK102915
K181989
Apr 21, 2021RAYSEARCH LABORATORIES AB
RayStation (Treatment Planning System) Model Number RayStation is 6.0.0.24 , 6.1.1.2 , 6.2.0.7 , 6.3.0.6 , 7.0.0.19 , 8.0.0.6 , 8.0.1.10 , 8.1.0.47 , 8.1.1.8 , 8.1.2.5 , 9.0.0.113 , 9.1.0.
Terminated
MUJK200569
Apr 7, 2021RAYSEARCH LABORATORIES AB
RayStation standalone software radiation therapy treatment planning system. Model Number: 8A, 8B, 9A, 9B, 10A, 10B including some service packs
Terminated
MUJK200569
Mar 25, 2021RAYSEARCH LABORATORIES AB
RayStation Model Number: (9A)9.0.0.113, 9B (9.1.0.933), 9B Service pack (9.2.0.483), 10A (10.0.0.1154), 10A Service pack (10.0.1.52), 10B (10.1.0.613)
Open, Classified
MUJK200569
Mar 3, 2021RAYSEARCH LABORATORIES AB
RayCare 3B (3.1.0.60341) - Product Usage: Intended Use Oncology information system that supports healthcare professionals in delivering cancer care.
Open, Classified
MUJK200487
Feb 22, 2021RAYSEARCH LABORATORIES AB
RayStation 4.5, 4.7, 4.9, 5, 6, 7, 8A, 8B, 9A, 9B, 10A, 10B, RayPlan 1, 2, 7, 8A, 8B, 9A, 10A, 10B including some of the Service Packs. Standalone software treatment planning system
Terminated
MUJK200569
Nov 11, 2020RAYSEARCH LABORATORIES AB
RayStation 4, 4.5, 4.7, 4.9, 5, 6, 7, 8A, 8B, 9A, 9B, RayPlan 1, 2, 7, 8A, 8B, 9A, 9B, including all service packs. RayStation 10A and RayPlan 10A are also affected, but not the 10A service pack. (Mod
Terminated
MUJK200569
Oct 8, 2020RAYSEARCH LABORATORIES AB
RayStation standalone software treatment planning system, Model No. 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, 9.1, 9.2, 10.0 - Product Usage: RayStation is a software system for
Terminated
MUJK200569
Aug 19, 2020Siemens Medical Solutions USA, Inc
Software: Syngo.via RT Image Suite software version VA30_SP02 with license T_RT_IMAGE_SUITE_PAT_MARK Intended Use: used as an advanced application on a SOM10 scanner SMN: 10496180
Terminated
MUJK192065
Jul 29, 2020RAYSEARCH LABORATORIES AB
RayCare, device is stand-alone software - Product Usage: used to support workflows and scheduling, as well as clinical information, planning and treatment management for oncology care.
Open, Classified
MUJK200487
Jun 24, 2020Siemens Medical Solutions USA, Inc
syngo.via RT Image Suite with software versions syngo.via VB30 or VB40
Terminated
MUJK192065
May 26, 2020RAYSEARCH LABORATORIES AB
RayStation standalone software treatment planning system (RayStation 8A, 8B, 9A, and 9B, including all service packs) model no. 8.0, 8.1, 9.0, 9.1, 9.2
Open, Classified
MUJK190387
May 18, 2020RAYSEARCH LABORATORIES AB
RayStation 7, UDI # 07350002010068 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments.
Terminated
MUJK190387
May 18, 2020RAYSEARCH LABORATORIES AB
RayStation 6 Service Pack 1, UDI #s 07350002010037, 07350002010082 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments.
Terminated
MUJK190387
May 18, 2020RAYSEARCH LABORATORIES AB
RayStation 9B Service Pack 1, UDI # 07350002010297 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments.
Terminated
MUJK190387
May 18, 2020RAYSEARCH LABORATORIES AB
RayStation 9B, UDI # 07350002010266 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments.
Terminated
MUJK190387
May 18, 2020RAYSEARCH LABORATORIES AB
RayStation 9A, UDI # 07350002010174 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments.
Terminated
MUJK190387
May 18, 2020RAYSEARCH LABORATORIES AB
RayStation 8B Service Pack 2, UDI # 07350002010235 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments.
Terminated
MUJK190387
May 18, 2020RAYSEARCH LABORATORIES AB
RayStation 8B Service Pack 1, UDI # 07350002010204 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments.
Terminated
MUJK190387
May 18, 2020RAYSEARCH LABORATORIES AB
RayStation 8B, UDI # 07350002010129 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments.
Terminated
MUJK190387
May 18, 2020RAYSEARCH LABORATORIES AB
RayStation 8A Service Pack 1, UDI # 07350002010136 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments.
Terminated
MUJK190387
May 18, 2020RAYSEARCH LABORATORIES AB
RayStation 8A, UDI # 07350002010112 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments.
Terminated
MUJK190387
May 18, 2020RAYSEARCH LABORATORIES AB
RayStation 6 Service Pack 3, UDI # 07350002010242 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments.
Terminated
MUJK190387
May 18, 2020RAYSEARCH LABORATORIES AB
RayStation 6 Service Pack 2, UDI # 07350002010075 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments.
Terminated
MUJK190387
May 18, 2020RAYSEARCH LABORATORIES AB
RayStation 6, UDI # 07350002010013 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments.
Terminated
MUJK190387
May 18, 2020RAYSEARCH LABORATORIES AB
RayStation 5 Service Pack 3, UDI # 07350002010020 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments.
Terminated
MUJK190387
May 18, 2020RAYSEARCH LABORATORIES AB
RayStation 4.0 to RayStation 5 Service Pack 2 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments.
Terminated
MUJK190387
Apr 16, 2020Elekta Inc
Elekta MONACO RTP Sytem, radiation treatment planning software system - Product Usage: The Monaco system is used to make treatment plans for patients with prescriptions for external beam radiation the
Open, Classified
MUJK183037
Mar 26, 2020Elekta Impac Software
MOSAIQ, oncology information system - Product Usage: MOSAIQ is an oncology information system used to manage workflows for treatment planning and delivery.
Open, Classified
MUJK141572
Mar 4, 2020RAYSEARCH LABORATORIES AB
RayStation standalone software treatment planning system, Model Numbers 4.0, 4.5, 4.7, 4.9, 5.0, 6.0, 7.0, 8.0, 8.1, 9.0, 9.1 - Product Usage: RayStation is a software system for radiation therapy and
Open, Classified
MUJK190387
Feb 20, 2020RAYSEARCH LABORATORIES AB
RayStation/RayPlan 9B, Build Number 9.1.0.933, stand-alone software treatment planning system
Terminated
MUJK190387
Feb 20, 2020RAYSEARCH LABORATORIES AB
RayStation/RayPlan 9A, Build Number 9.0.0.113, stand-alone software treatment planning system
Terminated
MUJK190387

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