Accelerator, Linear, Medical

Product Code: IYE

Radiology Medical Accelerators

Applicable Standards: No Standard Applicable. General Radiological Health Requirements Apply. [1000-1005]

Code of Federal Regulations: 892.5050


Radiation TypeIonizing
Radition SafetyAbbreviated
Annual ReportsYes

Products Classified as IYE

5321Accelerator, Linear, MedicalMedical Charged-particle Radiation Therapy System.

Total Product Life Cycle (TPLC) Devices

5321Accelerator, Linear, MedicalMedical Charged-particle Radiation Therapy System.

FDA Consensus Standards

Accelerator, Linear, Medical [31229]21 CFR §892.5050 πŸ”Ž
Accelerator, Linear, Medical [28999]21 CFR §892.5050 πŸ”Ž
Accelerator, Linear, Medical [34832]21 CFR §892.5050 πŸ”Ž
Accelerator, Linear, Medical [32775]21 CFR §892.5050 πŸ”Ž
Accelerator, Linear, Medical [37591]21 CFR §892.5050 πŸ”Ž
Accelerator, Linear, Medical [29957]21 CFR §892.5050 πŸ”Ž
Accelerator, Linear, Medical [36429]21 CFR §892.5050 πŸ”Ž
Accelerator, Linear, Medical [31233]21 CFR §892.5050 πŸ”Ž
Accelerator, Linear, Medical [32087]21 CFR §892.5050 πŸ”Ž

Pre-market Notifications for IYE

K212794Accuray Precision Treatment Planning SystemAccuray Incorporated
K212606BeamSiteDoseOptics LLC
K212583AlignRT PlusVision RT Ltd
K212294Ethos Treatment Management, Ethos Treatment PlanningVarian Medical Systems, Inc.
K212114Elekta UnityElekta Solutions AB
K211939ExacTrac DynamicBrainlab AG
K211663Zap-X Radiosurgical SystemZap Surgical Systems, Inc.
K211590Fiducial MarkerCarbon Medical Technologies Inc.
K211001C-Qual Mβ„’ Breastboard; Monarchβ„’ Overhead Arm PositionerMEDTEC, Inc. Dba CIVCO Medical Solutions And CIVCO
K210500Elekta Synergy, Elekta Harmony, Elekta Infinity, Versa HDElekta Limited
K203722RayPilot SystemMicropos Medical AB
K203669Mobius3DVarian Medical Systems, Inc.
K203387AlignRT PlusVision RT Ltd
K203172MOSAIQ Oncology Information SystemElekta Solutions AB
K202747Klarity BolusKlarity Medical & Equipment (GZ) Co., Ltd.

Global Unique Device Identification Database

00811376030023Accelerator, Linear, Medical
M65806600000Accelerator, Linear, Medical
M65810600000Accelerator, Linear, Medical
00754014600090Accelerator, Linear, Medical
00754014600083Accelerator, Linear, Medical
00815212023002Accelerator, Linear, Medical
00815212022906Accelerator, Linear, Medical
00815212022890Accelerator, Linear, Medical
00815212022869Accelerator, Linear, Medical
00815212022845Accelerator, Linear, Medical
00815212022784Accelerator, Linear, Medical
00815212022777Accelerator, Linear, Medical
00815212022753Accelerator, Linear, Medical
00815212022746Accelerator, Linear, Medical
00815212022739Accelerator, Linear, Medical

Maude Adverse Events

MOSAIQELEKTA INC2020-03-27
ELEKTA UNITYELEKTA LTD2020-03-26
ELEKTA UNITYELEKTA LTD2020-03-25
C4D SOFTWAREC-RAD POSITIONING AB2020-03-16
MOSAIQELEKTA INC2020-03-06
MOSAIQELEKTA INC2020-02-21
MOSAIQELEKTA INC2020-02-07
MOSAIQELEKTA INC2020-02-06
VARIAN TRUEBEAM H193889VARIAN MEDICAL SYSTEMS2020-02-04
ARTISTE MV SYSTEMSIEMENS HEALTHCARE GMBH2020-02-03
MOSAIQELEKTA INC2020-01-31
MOSAIQELEKTA INC2020-01-30
ONCOR IMPRESSION PLUSSIEMENS HEALTHCARE GMBH2020-01-21
ARTISTE MV SYSTEMSIEMENS HEALTHCARE GMBH2020-01-14
ACCELERATOR, LINEAR, MEDICALVARIAN MEDICAL SYSTEMS, INC.2020-01-07
MOSAIQELEKTA INC2020-01-03
RADIXACTACCURAY INCORPORATED2020-01-03
MOSAIQELEKTA INC2020-01-03
MRIDIAN SYSTEMSVIEWRAY, INC.2019-11-22
MOSAIQELEKTA INC2019-11-21
PRIMUS HISIEMENS HEALTHCARE GMBH2019-11-18
ARTISTE MV SYSTEMSIEMENS HEALTHCARE GMBH2019-11-11
ARTISTE SYNGO RT THERAPISTSIEMENS HEALTHCARE GMBH2019-11-11
CYBERKNIFEACCURAY INCORPORATED2019-11-04
ARTISTE MV SYSTEMSIEMENS HEALTHCARE GMBH2019-11-04
ELEKTA INFINITYELEKTA LTD2019-11-01
MOSAIQELEKTA INC2019-10-31
MOSAIQELEKTA INC2019-10-31
MOSAIQELEKTA INC2019-10-24
ONCOR AVANT GARDESIEMENS HEALTHCARE GMBH2019-10-18
ARTISTE MV SYSTEMSIEMENS HEALTHCARE GMBH2019-09-27
MOSAIQELEKTA INC2019-09-26
MOSAIQELEKTA INC2019-09-19
MOSAIQELEKTA INC2019-09-19
MOSAIQELEKTA INC2019-09-19
MOSAIQELEKTA INC2019-09-13
MOSAIQELEKTA INC2019-09-12
MOSAIQELEKTA INC2019-09-12
COHERENCE ONCOLOGISTSIEMENS HEALTHCARE GMBH2019-09-03
TOMOTHERAPY H SERIESACCURAY INCORPORATED2019-08-30
RADIXACTACCURAY INCORPORATED2019-08-26
SUNCHECK - DOSECHECK MODULESUN NUCLEAR CORPORATION2019-08-12
ONCOR IMPRESSION PLUSSIEMENS HEALTHCARE GMBH2019-08-09
MOSAIQELEKTA INC2019-08-08
DOSECHECK (PART OF SUNCHECK)SUN NUCLEAR CORPORATION2019-07-18
MOSAIQELEKTA INC2019-07-04
PRIMEVIEW 3ISIEMENS HEALTHCARE GMBH2019-07-02
ONCOR IMPRESSION PLUSSIEMENS HEALTHCARE GMBH2019-07-02
CYBERKNIFE M6ACCURAY INCORPORATED2019-06-27
ELEKTA SYNERGYELEKTA LTD2019-06-20

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