Product Code: MUJ


Products Classified as MUJ

5396System, Planning, Radiation Therapy TreatmentMedical Charged-particle Radiation Therapy System.

Total Product Life Cycle (TPLC) Devices

5396System, Planning, Radiation Therapy TreatmentMedical Charged-particle Radiation Therapy System.

FDA Consensus Standards

System, Planning, Radiation Therapy Treatment [31229]21 CFR §892.5050 🔎
System, Planning, Radiation Therapy Treatment [28999]21 CFR §892.5050 🔎
System, Planning, Radiation Therapy Treatment [34832]21 CFR §892.5050 🔎
System, Planning, Radiation Therapy Treatment [32775]21 CFR §892.5050 🔎
System, Planning, Radiation Therapy Treatment [36429]21 CFR §892.5050 🔎
System, Planning, Radiation Therapy Treatment [32087]21 CFR §892.5050 🔎

Pre-market Notifications for MUJ

K220783Syngo.via RT Image SuiteSiemens Medical Solutions USA Inc.
K220141RayStation 11BRaySearch Laboratories AB (publ)
K214081MRCAT Head & NeckPhilips Oy
K2134383D Bolus Software Application, 3D Brachy Software Application, Patient-Matched 3D Printed Radiation Therapy AccessoryAdaptiiv
K212274INT ContourCarina Medical LLC
K211881AI SegmentationVarian Medical Systems, Inc.
K211867RayStation 11.0RaySearch Laboratories AB (publ)
K211841MRI PlannerSpectronic Medical AB
K211511Decimal Bolus.decimal, LLC
K211379Syngo.via RT Image SuiteSiemens Medical Solutions USA Inc.
K211034Corvus Radiation Therapy Planning SystemBest Nomos
K2037664D Integrated Treatment ConsoleVarian Medical Systems, Inc.
K203681RT Elements, Cranial SRS W/ Cones, Multiple Brain Mets SRS, Cranial SRS, Spine SRS, RT QA, Dose ReviewBrainlab AG
K203469AI SegmentationVarian Medical Systems, Inc.
K202284OncospaceOncospace, Inc.

Global Unique Device Identification Database

00884838084667System, planning, radiation therapy treatment
00868603000236System,Planning,Radiation Therapy Treatment
00861572000313System,Planning,Radiation Therapy Treatment
00861572000306System,Planning,Radiation Therapy Treatment
00859032007002System, Planning, Radiation Therapy Treatment
00858164002244System, Planning, Radiation Therapy Treatment
00858164002213System,Planning,Radiation Therapy Treatment
00858164002206System,Planning,Radiation Therapy Treatment
00858164002190System, Planning, Radiation Therapy Treatment
00858164002183System,Planning,Radiation Therapy Treatment
00858164002169System,Planning,Radiation Therapy Treatment
00858164002152System,Planning,Radiation Therapy Treatment
00858164002114System,Planning,Radiation Therapy Treatment
00858164002046System,Planning,Radiation Therapy Treatment
00858164002039System,Planning,Radiation Therapy Treatment

Maude Adverse Events

SYNGO RT DOSIMETRIST 2.7 SYSTEMSIEMENS HEALTHCARE GMBH2020-03-30
MONACOELEKTA INC.2020-03-27
MONACOELEKTA INC.2020-03-27
MONACOELEKTA INC.2020-03-27
MONACOELEKTA INC.2020-03-19
RADIATION THERAPYUNKNOWN2020-02-28
MONACOELEKTA INC.2020-02-19
RAYSTATION 9ARAYSEARCH LABORATORIES AB (PUBL)2019-12-31
MONACOELEKTA INC.2019-11-26
MONACOELEKTA INC2019-11-07
MONACOELEKTA INC.2019-10-02
ECLIPSEVARIAN MEDICAL SYSTEMS2019-09-26
16.2.1 PINNACLE3 SWPHILIPS MEDICAL SYSTEMS2019-09-25
MONACOELEKTA INC2019-08-16
MONACOELEKTA INC2019-08-16
MONACOELEKTA INC.2019-08-01
MONACOELEKTA INC.2019-08-01
MONACOELEKTA INC2019-07-17
SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGINGPHILIPS MEDICAL SYSTEMS2019-06-26
MONACOELEKTA INC.2019-06-07
MONACOELEKTA INC.2019-06-06
MONACOELEKTA INC.2019-05-30
RAYSTATIONRAYSEARCH LABORATORIES AB (PUBL)2019-05-28
MONACOELEKTA INC.2019-05-02
SYNGO VSIMSIEMENS HEALTHCARE GMBH2019-04-08
MONACOELEKTA INC.2019-03-27
MONACOELEKTA INC.2019-03-13
MONACOELEKTA INC2019-01-11
RADIATION 200GY TOTAL 6000GY2018-12-26
ECLIPSEVARIAN MEDICAL SYSTEMS2018-12-21
16.2 PINNACLE3 SWPHILIPS MEDICAL SYSTEMS2018-11-23
MONACOELEKTA INC2018-11-22
ECLIPSEVARIAN MEDICAL SYSTEMS2018-11-19
16.2 PINNACLE3 SWPHILIPS MEDICAL SYSTEMS2018-09-27
16.2 PINNACLE3 SWPHILIPS MEDICAL SYSTEMS2018-08-31
MONACOELEKTA INC2018-08-22
RADIATION THERAPYUNK2018-08-13
RADIATION THERAPYUNK2018-08-07
RAYSTATIONRAYSEARCH LABORATORIES AB (PUBL)2018-07-13
RAYSTATIONRAYSEARCH LABORATORIES AB (PUBL)2018-07-10
MONACOELEKTA INC2018-07-05
MONACOELEKTA INC.2018-06-21
RAYSTATIONRAYSEARCH LABORATORIES AB (PUBL)2018-06-18
MONACOELEKTA INC.2018-02-01
MONACOELEKTA INC.2018-02-01
MONACOELEKTA INC.2018-01-25
MONACOELEKTA INC2018-01-24
RAYSTATIONRAYSEARCH LABORATORIES AB (PUBL)2018-01-19
TOMOTHERAPY HDACCURAY2018-01-12
MONACOELEKTA INC2018-01-12
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