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
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 29, 2021 | K210645 | RayStation 10.1 RaySearch Laboratories AB (PUBL), SE | MUJ |
| May 6, 2021 | K211034 | Corvus Radiation Therapy Planning System Best Nomos | MUJ |
| Apr 19, 2021 | K203469 | AI Segmentation Varian Medical Systems, Inc. | MUJ |
| Apr 9, 2021 | K203681 | RT Elements, Cranial SRS w/ Cones, Multiple Brain Mets SRS, Cranial SRS, Spine SRS, RT QA, Dose Review Brainlab AG, DE | MUJ |
| Mar 12, 2021 | K202284 | Oncospace Oncospace, Inc. | MUJ |
| Feb 23, 2021 | K202789 | Monaco Rtp System Elekta Solutions AB, SE | MUJ |
| Feb 12, 2021 | K203766 | 4D Integrated Treatment Console Varian Medical Systems, Inc. | MUJ |
| Sep 24, 2020 | K200569 | RayStation RaySearch Laboratories AB (PUBL), SE | MUJ |
| Sep 20, 2020 | K201350 | CORVUS Best Nomos | MUJ |
| Aug 13, 2020 | K201444 | Syngo.via RT Image Suite Siemens Medical Solutions USA, Inc. | MUJ |
| Jul 10, 2020 | K201607 | Eclipse Treatment Planning System v16.1 Varian Medical Systems, Inc. | MUJ |
| Jun 10, 2020 | K200487 | RayCare 3.1 RaySearch Laboratories AB (PUBL), SE | MUJ |
| Apr 27, 2020 | K193459 | Panther Stereotactic Prowess, Inc. | MUJ |
| Apr 9, 2020 | K193640 | ClearCalc Radformation, Inc. | MUJ |
| Apr 3, 2020 | K200608 | Eclipse Treatment Planning System v16.0 Varian Medical Systems, Inc. | MUJ |
| Jan 24, 2020 | K193109 | MRCAT brain Philips Medical Systems MR Finland, FI | MUJ |
| Dec 31, 2019 | K193381 | RadCalc Software Lifeline Software, Inc. | MUJ |
| Dec 13, 2019 | K192554 | decimal3D .Decimal, LLC | MUJ |
| Sep 18, 2019 | K192065 | Syngo.Via RT Image Suite Siemens Medical Solutions USA, Inc. | MUJ |
| Jul 8, 2019 | K191384 | RayCare 2.3 RaySearch Laboratories AB (PUBL), SE | MUJ |
| Jun 19, 2019 | K190387 | RayStation RaySearch Laboratories AB (PUBL), SE | MUJ |
| Apr 30, 2019 | K182888 | MRCAT Pelvis Philips Medical Systems MR Finland, FI | MUJ |
| Apr 12, 2019 | K190664 | RT Elements, Cranial SRS, Spine SRS, Multiple Brain Mets SRS, RT QA, Adaptive Hybrid Surgery Analysis, Dose Review Brainlab AG, DE | MUJ |
| Mar 29, 2019 | K190178 | Monaco RTP System Elekta, Inc. | MUJ |
| Feb 21, 2019 | K182665 | Sensus TPS Workstation Sensus Healthcare, Inc. | MUJ |
| Dec 4, 2018 | K183037 | Monaco RTP System Elekta, Inc. | MUJ |
| Jul 10, 2018 | K180289 | 3D Bolus Software 3D Bolus, Inc., CA | MUJ |
| May 18, 2018 | K181145 | Eclipse Treatment Planning System Varian Medical Systems, Inc. | MUJ |
| May 15, 2018 | K173940 | Astroid Planning App .Decimal, LLC | MUJ |
| Apr 25, 2018 | K180379 | RayStation 7 RaySearch Laboratories AB (PUBL), SE | MUJ |
| Mar 27, 2018 | K180308 | Prelude Medcom GmbH, DE | MUJ |
| Jan 12, 2018 | K173635 | syngo.via RT Image Suite Siemens Medical Solutions USA, Inc. | MUJ |
| Aug 24, 2017 | K170750 | RT Elements, Cranial SRS, Spine SRS, Multiple Brain Mets SRS, RT QA, Adaptive Hybrid Surgery Analysis, Dose Review Brainlab AG, DE | MUJ |
| Aug 15, 2017 | K172163 | Eclipse Treatment Planning System Varian Medical Systems, Inc. | MUJ |
| Jul 25, 2017 | K171885 | Radiance V4 Gmv Soluciones Globales Internet S.A.U., ES | MUJ |
| Jul 5, 2017 | K170969 | Eclipse Treatment Planning System Varian Medical Systems, Inc. | MUJ |
| Jun 27, 2017 | K171536 | RayStation RaySearch Laboratories AB (PUBL), SE | MUJ |
| Mar 2, 2017 | K170355 | RayStation 6 RaySearch Laboratories AB (PUBL), SE | MUJ |
| Feb 9, 2017 | K170086 | Pinnacle Radiation Therapy Planning System Philips Medical Systems (Cleveland), Inc. | MUJ |
| Oct 25, 2016 | K162370 | syngo.via RT Image Suite Siemens Medical Solutions USA, Inc. | MUJ |
| Jun 24, 2016 | K161136 | Precision Treatment Planning System Accuray Incorporated | MUJ |
| Apr 8, 2016 | K160093 | RayStation RaySearch Laboratories AB (PUBL), SE | MUJ |
| Feb 25, 2016 | K151435 | MRCAT Philips Medical Systems MR Finland, FI | MUJ |
| Feb 16, 2016 | K153368 | Radiance V3 Gmv Soluciones Globales Internet S.A.U., ES | MUJ |
| Dec 11, 2015 | K143514 | Panther StereoSeed Prowess, Inc. | MUJ |
| Nov 25, 2015 | K151469 | CORVUS Radiation Therapy Planning System Best Nomos | MUJ |
| Sep 28, 2015 | K152488 | Onrad Treatment System Accuray Incorporated | MUJ |
| Sep 18, 2015 | K152393 | Eclipse Treatment Planning System Varian Medical Systems, Inc. | MUJ |
| Sep 16, 2015 | K151887 | syngo VSim Siemens Medical Solutions USA, Inc. | MUJ |
| Sep 11, 2015 | K151560 | QuickPlan Siris Medical | MUJ |
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