ClearanceBrief
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)
Aug 6, 2019Siemens Medical Solutions USA, Inc
Lantis 8.3 Commander, Model # 8148178 - Product Usage: Lantis Treatstation is to allow the radiation therapist to deliver treatment to the patient using the mevatron and all available accessories. Thi
Terminated
IYEK972275
Aug 6, 2019Siemens Medical Solutions USA, Inc
Lantis 6.1 Commander, Model # 5493072 - Product Usage: Lantis Treatstation is to allow the radiation therapist to deliver treatment to the patient using the mevatron and all available accessories. Thi
Terminated
IYEK972275
Jul 18, 2019Medical Intelligence Medizintechnik Gmbh
IGuide System, software versions: 2.2.0, 2.2.1, 2.2.2 Product Usage: Linear Accelerator. The intended use of the device is the control of accurate patient positioning with assistance of a 30 Trackin
Terminated
IYEK072079
Jul 16, 2019Elekta, Inc.
Elekta Unity, Image-Guided Radiation Therapy System Elekta Unity using Magnetic Resonance Imaging is indicated for radiation therapy treatments and stereotactic radiation treatments of malignant and
Terminated
IYEK182076
Jun 19, 2019Elekta, Inc.
iGUIDE System with software build iGuide 2.2.0, 2.2.1, and 2.2.2
Terminated
IYEK072079
May 8, 2019Elekta Limited
Elekta Unity systems Product Usage: Elekta Unity using Magnetic Resonance Imaging is indicated for radiation therapy treatments and stereotactic radiation treatments of malignant and benign diseases
Terminated
IYEK182076
Apr 15, 2019Med Tec Inc
CIVCO Solstice(TM) SRS Immobilization System, Part Numbers: a) CHS03, b) CHS04 - Product Usage: The Tilting Head Fixation (Solstice) device is comprised of a baseplate and bowl with a locking lever.
Terminated
IYEK182079
Mar 20, 2019Siemens Medical Solutions USA, Inc
Siemens Digital Linear Accelerators of type: ARTISTE MV System MEVATRON M2/Primus Mid-Energy PRIMUS PRIMUS HI ONCOR Impression ONCOR Impression Plus ONCOR Avant Garde ONCOR Expression ARTISTE, ONCOR,
Terminated
IYEK031764
K060226 +3
Mar 18, 2019Viewray, Inc.
MRIdian Linac Radiation Therapy System, Model 20000.
Terminated
IYEK170751
Mar 12, 2019Elekta Limited
Elekta Unity, Image-Guided Radiation Therapy System Product Usage: Elekta Unity using Magnetic Resonance Imaging is indicated for radiation therapy treatments and stereotactic radiation treatments of
Terminated
IYEK182076
Jan 4, 2019Elekta Limited
Elekta Unity
Completed
IYEK182076
Dec 13, 2018Elekta, Inc.
MOSAIQ Oncology Information System and Sequencer MOSAIQ is an oncology information system used to manage workflows for treatment planning and delivery. It supports information flow among healthcare f
Open, Classified
IYEK120067
K123230 +2
Dec 4, 2018Elekta, Inc.
MOSAIQ Oncology Information System Version 2.64. MOSAIQ is an oncology information system used to manage workflows for treatment planning and delivery
Terminated
IYEK141572
Sep 26, 2018Accuray Incorporated
CyberKnife M6, Part Number 054000-004 The CyberKnife M6 Systems are indicated for treatment planning and image guided stereotactic radiosurgery and precision radiotherapy for lesions, tumors and con
Terminated
IYEK150873
Sep 20, 2018Accuray Incorporated
Ashland(TM) Box Film Ball Cube II EBT3, P/N: 027863-002 rev E Product is used to calibrate CyberKnife systems
Terminated
IYENone listed
Aug 24, 2018Vision RT Ltd
Integrated Gate Controller PCB (component of AlignRT Plus) Truebeam variant only. The AlignRT is a video-based three-dimensional (3D) surface imaging system which is used to image the skin surface o
Terminated
IYEK123371
Aug 20, 2018Varian Medical Systems
VitalBeam Radiotherapy Delivery System Version 2.5 Product Usage: The VitalBeam delivery systems are intended to provide precision radiotherapy and stereotactic radiosurgery for lesions, tumors, and
Terminated
IYEK150706
Aug 20, 2018Varian Medical Systems
TrueBeam Radiotherapy Delivery System version 2.0 and 2.5 EDGE Radiotherapy Delivery System version 2.0 and 2.5 Product Usage: The TrueBeam delivery systems are intended to provide radiotherapy and
Terminated
IYEK140528
K143224
Aug 3, 2018Elekta, Inc.
MOSAIQ Oncology Information System
Terminated
IYEK141572
Apr 10, 2018Accuray Incorporated
CyberKnife VSI, Part Numbers: a) 032500-010: CyberKnife VSI 9.6.x Robotic Radiosurgery System for Japan b) 033000-010: CyberKnife VSI Robotic Radiosurgery System
Terminated
IYENone listed
Apr 10, 2018Accuray Incorporated
CyberKnife M6, Part Numbers: a) 0660000: CyberKnife Treatment Delivery System b) 053101-010: CyberKnife M6 FI Treatment Delivery System c) 053201-010: CyberKnife M6 FM Treatment Delivery System d) 0
Terminated
IYEK150873
Feb 14, 2018Siemens Medical Solutions USA, Inc
PRIMUS HI, Digital Linear Accelerator, Model No. 04504200 Product Usage: The intended use of the device is to deliver x-ray radiation for therapeutic treatment of cancer.
Terminated
IYEK993425
Feb 14, 2018Siemens Medical Solutions USA, Inc
ONCOR Impression Plus, Digital Linear Accelerator, Model No. 05857912 Product Usage: The intended use of the device is to deliver x-ray radiation for therapeutic treatment of cancer.
Terminated
IYEK121295
Feb 14, 2018Siemens Medical Solutions USA, Inc
ONCOR Impression , Digital Linear Accelerator, Model No. 05857920 Product Usage: The intended use of the device is to deliver x-ray radiation for therapeutic treatment of cancer.
Terminated
IYEK060226
Feb 14, 2018Siemens Medical Solutions USA, Inc
ONCOR Expression, Digital Linear Accelerator, Model No. 07360717 Product Usage: The intended use of the device is to deliver x-ray radiation for therapeutic treatment of cancer.
Terminated
IYEK060226
Feb 14, 2018Siemens Medical Solutions USA, Inc
ONCOR Avant-garde, Digital Linear Accelerator, Model No. 05863472 Product Usage: The intended use of the device is to deliver x-ray radiation for therapeutic treatment of cancer.
Terminated
IYEK031764
Feb 14, 2018Siemens Medical Solutions USA, Inc
MEVATRON M2 / PRIMUS Mid-Energy, Digital Linear Accelerator, Model No. 01940035 Product Usage: The intended use of the device is to deliver x-ray radiation for therapeutic treatment of cancer.
Terminated
IYEK993425
Feb 14, 2018Brainlab AG
ExacTrac versions 6.5 through 6.5 intended to be used to place patients at an accurately defined point within the treatment beam of a medical accelerator for stereotactic radiosurgery or radiotherapy
Terminated
IYEK120789
Dec 8, 2017Hitachi Ltd., Medical System Operations Group
MHI-TM2000 Linear Accelerator System Product Usage: MHI-TM2000 Linear Accelerator System is intended for radiation therapy of lesions, tumors and conditions anywhere in the body where radiation treat
Terminated
IYEK072047
K122450 +1
Dec 1, 2017Elekta, Inc.
ELEKTA Digital Accelerator under the following brand names: Elekta Synergy, Synergy S, Synergy Platform, Precise Digital Accelerator, Infinity, Axesse, and Versa HD
Terminated
IYEK051932
Nov 20, 2017Elekta Limited
Integrity R1.2
Terminated
IYEK112613
Nov 20, 2017Elekta Limited
Agility with Integrity R3.2
Terminated
IYEK123808
Nov 17, 2017Accuray Incorporated
TomoHDA(R) System, Model Number 1018286 Product Usage: The TomoTherapy treatment system is intended to be used as an integrated system for t he planning and precise delivery of radiation therapy, ste
Terminated
IYEK121934
Nov 17, 2017Accuray Incorporated
TomoH(R) System, Model Number 1018284 Product Usage: The TomoTherapy treatment system is intended to be used as an integrated system for t he planning and precise delivery of radiation therapy, stere
Terminated
IYEK121934
Nov 17, 2017Accuray Incorporated
TomoHD(R) System, Model Number 1018283 Product Usage: The TomoTherapy treatment system is intended to be used as an integrated system for t he planning and precise delivery of radiation therapy, ster
Terminated
IYEK121934
Nov 17, 2017Accuray Incorporated
Hi-Art(R) System, Model Number H-000-0003 Product Usage: The TomoTherapy treatment system is intended to be used as an integrated system for t he planning and precise delivery of radiation therapy, s
Terminated
IYEK121934
Nov 3, 2017Brainlab AG
BRAINLAB EXACTRAC VERO, Model/Catalog Numbers: 46228 EXACTRAC VERO 3.5 46238 EXACTRAC VERO 3.5 46216 EXACTRAC VERO SW UPDATE 3.5.2 TO 3.5.3 46218 EXACTRAC VERO SW UPDATE 3.5.3 TO 3.5.4 The ExacTrac
Terminated
IYEK122451
Jun 21, 2017Elekta, Inc.
MOSAIQ(R) Oncology Information System, Versions 2.50.05 and higher Product Usage: MOSAIQ is an oncology information system used to manage workflows for treatment planning and delivery. It supports
Terminated
IYEK123230
Jun 19, 2017Elekta, Inc.
iGUIDE Software 2.2 Product Usage: Control of accurate patient positioning with assistance of a 30 Tracking System in a radiotherapy environment.
Terminated
IYEK143485
May 16, 2017Mobius Medical Systems, LP
Mobius3D Product Usage: Mobius3D software is used for quality assurance and treatment plan verification in radiation therapy. It calculates radiation dose three-dimensionally in a representation of a
Terminated
IYEK140660
Apr 26, 2017Iba Dosimetry
Large Stealth Chamber, Catalog Numbers: DS50-001-XL-T, DS50-002-XL-T, DS50-003-XL-T, DS50-102-XL-T, DS50-103-XL-T
Terminated
IYEK945321
Feb 14, 2017Siemens Medical Solutions USA, Inc
ONCOR" Expression ONCOR" Impression ONCOR" Impression plus
Terminated
IYEK060226
Feb 14, 2017Siemens Medical Solutions USA, Inc
ONCOR" Avant-garde
Terminated
IYEK031764
Feb 14, 2017Siemens Medical Solutions USA, Inc
Mevatron M2/Primus Mid-Energy PRIMUS HI
Terminated
IYEK993425
Feb 14, 2017Siemens Medical Solutions USA, Inc
ARTISTE" MV System
Terminated
IYEK072485
Jan 25, 2017Siemens Medical Solutions USA, Inc
MEVATRON KD-2, accelerator, Linear, Medical The intended use of the SIEMENS branded PRIMUS family of linear accelerator systems is to deliver x-ray radiation for therapeutic treatment of cancer
Terminated
IYEK862339
Jan 25, 2017Siemens Medical Solutions USA, Inc
MEVATRON MD-2, MEVATRON MDX-2 and MEVATRON ME, accelerator, Linear, Medical The intended use of the SIEMENS branded PRIMUS family of linear accelerator systems is to deliver x-ray radiation for therap
Terminated
IYEK882729
Jan 25, 2017Siemens Medical Solutions USA, Inc
MEVATRON M 7400/7440(MEX) Accelerator, Linear, Medical The intended use of the SIEMENS branded PRIMUS family of linear accelerator systems is to deliver x-ray radiation for therapeutic treatment of ca
Terminated
IYEK791967
Jan 25, 2017Siemens Medical Solutions USA, Inc
MEVATRON M 6730/6740 (MEX) Accelerator, Linear, Medical The intended use of the SIEMENS branded PRIMUS family of linear accelerator systems is to deliver x-ray radiation for therapeutic treatment of c
Terminated
IYEK812032
Jan 25, 2017Siemens Medical Solutions USA, Inc
MEVATRON M 6700 (MX) Accelerator, Linear, Medical The intended use of the SIEMENS branded PRIMUS family of linear accelerator systems is to deliver x-ray radiation for therapeutic treatment of cancer
Terminated
IYEK790688

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