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Panels › Radiology › Product code IYE · Class 2

Accelerator, Linear, Medical

Regulation 892.5050

15510(k)s in 12 months (738 all time)
8recalls in 12 months (563 all time)
542recalls that name a 510(k)
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Top companies in IYE

DateFirm and productCodeLinked 510(k)
Jan 25, 2017Siemens Medical Solutions USA, Inc
PRIMUS HI and Mevatron M2/Primus Mid-Energy, Accelerator, Linear, Medical The intended use of the SIEMENS branded PRIMUS family of linear accelerator systems is to deliver x-ray radiation for therapeu
Terminated
IYEK993425
Jan 25, 2017Siemens Medical Solutions USA, Inc
PRIMUS Medical charged-particle radiation therapy system Product Usage: The intended use of the SIEMENS branded PRIMUS family of linear accelerator systems is to deliver x-ray radiation for therapeut
Terminated
IYEK993425
Jan 25, 2017Siemens Medical Solutions USA, Inc
ONCOR Impression, ONCOR Impression plus, and ONCOR Expression Medical charged-particle radiation therapy system Product Usage: The intended use of the SIEMENS branded PRIMUS family of linear accelera
Terminated
IYEK060226
Jan 25, 2017Siemens Medical Solutions USA, Inc
ONCOR Avant-garde, medical charged-particle radiation therapy system Product Usage: The intended use of the SIEMENS branded PRIMUS family of linear accelerator systems is to deliver x-ray radiation f
Terminated
IYEK031764
Jan 25, 2017Siemens Medical Solutions USA, Inc
ARTISTE MV System, medical charged-particle radiation therapy system Product Usage: The intended use of the SIEMENS branded PRIMUS family of linear accelerator systems is to deliver x-ray radiation f
Terminated
IYEK072485
Jan 10, 2017Varian Medical Systems, Inc.
Eclipse Treatment Planning System version 13.MR2 [13.06.31 with Smart Segmentation Knowledge Based Contouring version 2.3 [2.3.12] Radiology: The Eclipse Treatment Planning System (Eclipse TPS) is
Terminated
IYEK141283
Dec 21, 2016Accuray Incorporated
CyberKnife Robotic Radiosurgery Systems, models: G3, G4, VSI. Radiology: The CyberKnife Robotic Radiosurgery System is indicated for treatment planning and image guided stereotactic Radiosurgery and
Terminated
IYEK011024
Dec 12, 2016Accuray Incorporated
CyberKnife Robotic Radiosurgery System using software version 10.6; Catalog/Part Number: 54000 UDI: M658053301 0 Radiology: The CyberKnife Robotic Radiosurgery System is indicated for treatment plann
Terminated
IYEK122137
Dec 2, 2016Elekta, Inc.
MOSAIQ Oncology Information System The product is used to manage workflows for treatment planning and delivery. It supports information flow among healthcare facility personnel and can be use wherev
Terminated
IYEK141572
Oct 13, 2016Varian Medical Systems, Inc.
Varian Head Frame - Model number HHF -ALL Head Frame Posts (PN1008016 ) and Post Kits (PN1008016). The Varian Head Frame System is for use with a computed tomography scanner to perform imaging for t
Terminated
IYEK142560
Aug 30, 2016Elekta, Inc.
HexaPOD evo RT System Product Usage: The intended use of the device is the control of accurate patient positioning with assistance of a 3D Tracking System in a radiotherapy environment.
Terminated
IYEK072079
Jul 26, 2016Siemens Medical Solutions USA, Inc
Syngo RT Therapist, Accelerator, Linear, Medical Syngo RT Therapist is a software application whose indication for use includes the viewing, processing, filming, and archiving of medical images. It al
Terminated
IYEK090683
Jul 26, 2016Siemens Medical Solutions USA, Inc
PRIMUS, Accelerator, Linear, Medical The PRIMUSTM family of linear accelerator systems is to deliver x-ray radiation for therapeutic treatment of cancer
Terminated
IYEK993425
Jul 26, 2016Siemens Medical Solutions USA, Inc
ARTISTE, Accelerator, Linear, Medical The intended use of the SIEMENS branded ARTISTETM family of linear accelerator systems is to deliver X-Ray photon and electron radiation for the therapeutic treat
Terminated
IYEK103606
Jul 15, 2016Elekta, Inc.
MOSAIQ Oncology Information System
Open, Classified
IYEK123230
Jul 11, 2016Varian Medical Systems, Inc.
Optical Surface Monitoring System{Align RT Plus} This is used on Varian's TrueBeam EDGE; Radiology: The AlignRT Plus system is indicated for use to position and monitor patients relative to the presc
Terminated
IYEK123371
Jul 11, 2016Varian Medical Systems, Inc.
Optical Surface Monitoring System{OSMS, Varian Private Label} This is used on Varian's TrueBeam EDGE; Radiology: The AlignRT Plus system is indicated for use to position and monitor patients relative
Terminated
IYEK123371
Jul 8, 2016Elekta, Inc.
Medical Linear Accelerator
Terminated
IYEK051932
Jun 30, 2016Vision RT Ltd
TrueBeam Radiotherapy Delivery System and EDGE" Radiotherapy Delivery System, K140528. The TrueBeam and Edge Systems are intended to provide stereotactic radiosurgery and precision radiotherapy for l
Terminated
IYEK140528
Jun 30, 2016Vision RT Ltd
AlignRT Plus [private label-OSMS] K123371: The AlignRT Plus system is indicated for use to position and monitor patients relative to the prescribed treatment isocentre, and to withhold the beam autom
Terminated
IYEK123371
Jun 17, 2016Elekta, Inc.
MOSAIQ Oncology Information System
Terminated
IYEK141572
May 23, 2016Elekta, Inc.
iGUIDE System, for patient positioning, with assistance of a 30 Tracking System in a radiotherapy environment.
Terminated
IYEK072079
May 4, 2016Brainlab AG
ExacTrac Vero is a Patient Positioning System for Radiation therapy.
Terminated
IYEK122451
Mar 31, 2016Viewray Incorporated
MRIdian ViewRay Radiation Therapy System, ViewRay Treatment Planning and Delivery System (also known as the MRIdian System) is indicated for stereotactic radiosurgery and precision radiotherapy for le
Terminated
IYEK111862
Mar 31, 2016MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MACHINERY WORK
VERO MHI-TM2000 Linear Accelerator System --- Common Name: Medical Linear Accelerator MHI-TM2000 Linear Accelerator System is intended for radiation therapy of lesions, tumors and conditions anywhere
Terminated
IYEK072047
K122450 +1
Mar 25, 2016Wfr/aquaplast Corp
Clear Vue Prone Breast Treatment Table and Access ClearVision Prone Breast Device Product Usage: Clear Vue Prone Breast Treatment Table and Access ClearVision Prone Breast Device is a medical charge
Terminated
IYEK090349
Mar 24, 2016MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MACHINERY WORK
MHI-TM2000 Linear Accelerator System (Software Version 3.0.0 and after) Intended for radiation therapy of lesions, tumors. conditions anywhere in the body where radiation therapy is indicated.
Terminated
IYEK072047
K122450 +1
Feb 12, 2016Viewray Incorporated
MRIdian ViewRay Radiation Therapy System, VIEWRAY Inc.
Terminated
IYEK111862
Feb 9, 2016Accuray Incorporated
CyberKnife Robotic; Catalog/part number 032000 and 033000 Cosmetic cover package. Product Usage: The CyberKnife Robotic Radiosurgery System is indicated for treatment planning and image guided stereo
Terminated
IYEK120233
Feb 2, 2016Philips Medical Systems
DS/US Proton Feature with Pinnacle3 Software Version 10.0.0 and 14.0.0 Radiation Therapy Planning System Model #459800200621
Terminated
IYEK130992
Jan 21, 2016Iba Dosimetry Gmbh
IBA Dosimetry GmbH Lift Table Type 4320, Catalog HA03-010#2 and HA03-000#2
Terminated
IYEK945321
Dec 9, 2015Elekta, Inc.
MOSAIQ Oncology Information System MOSAIQ is an oncology information system used to manage workflows for treatment planning and delivery. It supports information flow among healthcare facility person
Terminated
IYEK141572
Nov 24, 2015Elekta, Inc.
MOSAIQ Oncology Information System. Used to manage workflows for treatment planning and delivery.
Terminated
IYEK141572
Oct 27, 2015Siemens Medical Solutions USA, Inc
ONCOR Avant Garde, ONCOR Impression Plus, ONCOR Expression, ONCOR Impression, PRIMUS HI, MEVATRON M2/PRIMUS Mid-Energy, ARTISTE; intended use is to deliver x-ray radiation for therapeutic treatment of
Terminated
IYEK031764
K060226 +2
Oct 9, 2015Viewray Incorporated
MRIdian ViewRay Radiation Therapy System, ViewRay Is indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body when radiation treatm
Terminated
IYEK111862
Oct 6, 2015Siemens Medical Solutions USA, Inc
Syngo RT Oncologist, an optional accessory to the linear accelerator system and permits localization, contouring, segmentation, image review, and review and approval of treatment plan parameters. In a
Terminated
IYEK142434
Sep 24, 2015Siemens Medical Solutions USA, Inc
ARTISTE, ONCOR Avantgarde, ONCOR Impression Plus, ONCOR Expression, PRIMUS, PRIMUS Plus, Syngo RT Therapist; therapeutic treatment of cancer Product Usage: The intended use of the SIEMENS branded AR
Terminated
IYEK031764
K060226 +3
Aug 21, 2015Brainlab AG
ExacTrac 6.0.x Patient Positioning System, Radiation therapy. Intended to be used to place patients at an accurately defined point within the treatment beam of a medical accelerator for stereotactic
Terminated
IYEK120789
Aug 21, 2015PTW-Freiburg
PTW UNIDOS webline: 1) REF T10023, 2) REF T10022 and 3) REF T10023 Firmware version 2.05. Dosimeter for radiation therapy, diagnostic radiology and health physics.
Terminated
IYEK951764
Jul 16, 2015Viewray Incorporated
Patient Handling System (Motion Control Software), Product Usage: Indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body when rad
Terminated
IYEK111862
Jul 14, 2015Elekta, Inc.
MOSAIQ Oncology Information System MOSAIQ is an oncology information system used to manage workflows for treatment planning and delivery. It supports information flow among healthcare facility personn
Terminated
IYEK141572
Jul 2, 2015Viewray Incorporated
Treatment Planning and Delivery System Software version 3.6. ViewRay. Indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body when
Terminated
IYEK111862
May 5, 2015Viewray Incorporated
ViewRay System, Radiation Therapy System
Terminated
IYEK111862
May 1, 2015MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MACHINERY WORK
MHI-TM2000 Linear Accelerator System (Software Version 3.5.0 and 3.5.1)
Terminated
IYEK072047
K122450
Mar 25, 2015Brainlab AG
ExacTrac versions 6.x patient positioning systems are used to position patients during radiosurgery or radiotherapy procedures..
Terminated
IYEK120789
Mar 18, 2015Siemens Medical Solutions USA, Inc
ARTISTE MV System, Linear Accelerator (LINAC) with SysVC10A software. The intended use of the ARTISTE MV System linear accelerator system is to deliver x-ray radiation for therapeutic treatment of c
Terminated
IYEK060226
Mar 16, 2015Siemens Medical Solutions USA, Inc
Siemens LANTIS Oncology Information System Servers; allows the radiation therapist to deliver treatment to patient using the MEVATRON and all available accessories
Terminated
IYEK972275
Feb 26, 2015Iba Dosimetry Gmbh
COMPASS SW Version 3.1, Catalog Number CS10-100, medical linear accelerator, radiological
Terminated
IYEK072374
Feb 10, 2015Elekta, Inc.
Precise Digital Accelerator Intended to be used for radiation therapy treatments of malignant neoplastic diseases, as determined by a licensed medical practitioner.
Terminated
IYEK051932
Feb 5, 2015Siemens Medical Solutions USA, Inc
LINAC Accelerators: ARTISTE, ONCOR Avant Garde, ONCOR Impression Plus, ONCOR Expression, ONCOR Impression, PRIMUS HI, Mevatron M2/Primus Mid-Energy, MEVATRON PRIMART, MEVATRON KD-2, MEVATRON K
Terminated
IYEK031764
K060226 +3

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