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) |
|---|---|---|---|
| Aug 25, 2023 | RAYSEARCH 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 |
MUJ | K200487 |
| Jun 29, 2023 | RaySearch 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 |
MUJ | K200569 |
| Mar 22, 2023 | RAYSEARCH 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 |
MUJ | K190387 |
| Mar 8, 2023 | Elekta Inc Monaco RTP System.
Used to make treatment plans for patients with prescriptions for external beam radiation therapy. Open, Classified |
MUJ | K151233 |
| Dec 15, 2022 | Elekta, Inc. Oncentra Brachy radiation therapy planning system software. Open, Classified |
MUJ | K132816 |
| Sep 15, 2022 | Philips Medical Systems (Cleveland) Inc Pinnacle3 Radiation Therapy Planning System, Model numbers 870231 and 870237. Open, Classified |
MUJ | K170086 |
| Jun 10, 2022 | RAYSEARCH LABORATORIES AB RayStation 11B Terminated |
MUJ | K220141 |
| Jun 1, 2022 | RAYSEARCH LABORATORIES AB RayStation 9B SP1. For radiation treatment planning. Terminated |
MUJ | K200569 |
| Mar 7, 2022 | Siemens 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 |
MUJ | K211379 |
| Feb 11, 2022 | RaySearch 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 |
MUJ | K211867 |
| Dec 30, 2021 | RAYSEARCH 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 |
MUJ | K211867 |
| Oct 13, 2021 | Elekta, Inc. Oncentra Brachy users using version 4.0 and above with Applicator Modeling license 170283-00 Open, Classified |
MUJ | K132816 |
| Sep 22, 2021 | RAYSEARCH 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 |
MUJ | K211867 |
| Sep 14, 2021 | Elekta Inc Elekta Monaco - Product Usage: used to make treatment plans for patients with prescriptions for external beam radiation therapy. Open, Classified |
MUJ | K183037 K190178 |
| Sep 10, 2021 | Siemens 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 |
MUJ | K211379 |
| Sep 9, 2021 | RAYSEARCH 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 |
MUJ | K210645 |
| Jul 26, 2021 | Elekta Inc Monaco RTP System, Software Builds 5.40.00, 5.40.01, 5.40.02, and 5.51.10 Open, Classified |
MUJ | K183037 K190178 |
| Jun 8, 2021 | RAYSEARCH 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 |
MUJ | K200487 K200569 |
| May 4, 2021 | Viewray, 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 |
MUJ | K102915 K181989 |
| Apr 21, 2021 | RAYSEARCH 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 |
MUJ | K200569 |
| Apr 7, 2021 | RAYSEARCH LABORATORIES AB RayStation standalone software radiation therapy treatment planning system.
Model Number: 8A, 8B, 9A, 9B, 10A, 10B including some service packs Terminated |
MUJ | K200569 |
| Mar 25, 2021 | RAYSEARCH 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 |
MUJ | K200569 |
| Mar 3, 2021 | RAYSEARCH 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 |
MUJ | K200487 |
| Feb 22, 2021 | RAYSEARCH 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 |
MUJ | K200569 |
| Nov 11, 2020 | RAYSEARCH 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 |
MUJ | K200569 |
| Oct 8, 2020 | RAYSEARCH 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 |
MUJ | K200569 |
| Aug 19, 2020 | Siemens 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 |
MUJ | K192065 |
| Jul 29, 2020 | RAYSEARCH 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 |
MUJ | K200487 |
| Jun 24, 2020 | Siemens Medical Solutions USA, Inc syngo.via RT Image Suite with software versions
syngo.via VB30 or VB40 Terminated |
MUJ | K192065 |
| May 26, 2020 | RAYSEARCH 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 |
MUJ | K190387 |
| May 18, 2020 | RAYSEARCH LABORATORIES AB RayStation 7, UDI # 07350002010068 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments. Terminated |
MUJ | K190387 |
| May 18, 2020 | RAYSEARCH 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 |
MUJ | K190387 |
| May 18, 2020 | RAYSEARCH 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 |
MUJ | K190387 |
| May 18, 2020 | RAYSEARCH LABORATORIES AB RayStation 9B, UDI # 07350002010266 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments. Terminated |
MUJ | K190387 |
| May 18, 2020 | RAYSEARCH LABORATORIES AB RayStation 9A, UDI # 07350002010174 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments. Terminated |
MUJ | K190387 |
| May 18, 2020 | RAYSEARCH 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 |
MUJ | K190387 |
| May 18, 2020 | RAYSEARCH 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 |
MUJ | K190387 |
| May 18, 2020 | RAYSEARCH LABORATORIES AB RayStation 8B, UDI # 07350002010129 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments. Terminated |
MUJ | K190387 |
| May 18, 2020 | RAYSEARCH 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 |
MUJ | K190387 |
| May 18, 2020 | RAYSEARCH LABORATORIES AB RayStation 8A, UDI # 07350002010112 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments. Terminated |
MUJ | K190387 |
| May 18, 2020 | RAYSEARCH 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 |
MUJ | K190387 |
| May 18, 2020 | RAYSEARCH 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 |
MUJ | K190387 |
| May 18, 2020 | RAYSEARCH LABORATORIES AB RayStation 6, UDI # 07350002010013 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments. Terminated |
MUJ | K190387 |
| May 18, 2020 | RAYSEARCH 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 |
MUJ | K190387 |
| May 18, 2020 | RAYSEARCH 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 |
MUJ | K190387 |
| Apr 16, 2020 | Elekta 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 |
MUJ | K183037 |
| Mar 26, 2020 | Elekta 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 |
MUJ | K141572 |
| Mar 4, 2020 | RAYSEARCH 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 |
MUJ | K190387 |
| Feb 20, 2020 | RAYSEARCH LABORATORIES AB RayStation/RayPlan 9B, Build Number 9.1.0.933, stand-alone software treatment planning system Terminated |
MUJ | K190387 |
| Feb 20, 2020 | RAYSEARCH LABORATORIES AB RayStation/RayPlan 9A, Build Number 9.0.0.113, stand-alone software treatment planning system Terminated |
MUJ | K190387 |
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