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)
Top companies in IYE
| Company | 510(k)s | Recalls |
|---|---|---|
| Siemens Medical Solutions USA, Inc. | 18 | 206 |
| Varian Medical Systems | 83 | 27 |
| Elekta , Ltd. | 19 | 77 |
| Varian Medical Systems, Oncology Systems | 2 | 68 |
| Accuray Incorporated | 19 | 32 |
| Landauer | 1 | 39 |
| Brainlab | 22 | 17 |
| Varian Assoc., Inc. | 27 | 0 |
| Medtec, Inc. | 20 | 0 |
| Sun Nuclear Corp. | 19 | 1 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 6, 2019 | Siemens 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 |
IYE | K972275 |
| Aug 6, 2019 | Siemens 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 |
IYE | K972275 |
| Jul 18, 2019 | Medical 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 |
IYE | K072079 |
| Jul 16, 2019 | Elekta, 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 |
IYE | K182076 |
| Jun 19, 2019 | Elekta, Inc. iGUIDE System with software build iGuide 2.2.0, 2.2.1, and 2.2.2 Terminated |
IYE | K072079 |
| May 8, 2019 | Elekta 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 |
IYE | K182076 |
| Apr 15, 2019 | Med 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 |
IYE | K182079 |
| Mar 20, 2019 | Siemens 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 |
IYE | K031764 K060226 +3 |
| Mar 18, 2019 | Viewray, Inc. MRIdian Linac Radiation Therapy System, Model 20000. Terminated |
IYE | K170751 |
| Mar 12, 2019 | Elekta 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 |
IYE | K182076 |
| Jan 4, 2019 | Elekta Limited Elekta Unity Completed |
IYE | K182076 |
| Dec 13, 2018 | Elekta, 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 |
IYE | K120067 K123230 +2 |
| Dec 4, 2018 | Elekta, Inc. MOSAIQ Oncology Information System Version 2.64.
MOSAIQ is an oncology information system used to manage workflows for treatment planning and delivery Terminated |
IYE | K141572 |
| Sep 26, 2018 | Accuray 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 |
IYE | K150873 |
| Sep 20, 2018 | Accuray Incorporated Ashland(TM) Box Film Ball Cube II EBT3, P/N: 027863-002 rev E
Product is used to calibrate CyberKnife systems Terminated |
IYE | None listed |
| Aug 24, 2018 | Vision 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 |
IYE | K123371 |
| Aug 20, 2018 | Varian 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 |
IYE | K150706 |
| Aug 20, 2018 | Varian 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 |
IYE | K140528 K143224 |
| Aug 3, 2018 | Elekta, Inc. MOSAIQ Oncology Information System Terminated |
IYE | K141572 |
| Apr 10, 2018 | Accuray 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 |
IYE | None listed |
| Apr 10, 2018 | Accuray 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 |
IYE | K150873 |
| Feb 14, 2018 | Siemens 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 |
IYE | K993425 |
| Feb 14, 2018 | Siemens 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 |
IYE | K121295 |
| Feb 14, 2018 | Siemens 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 |
IYE | K060226 |
| Feb 14, 2018 | Siemens 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 |
IYE | K060226 |
| Feb 14, 2018 | Siemens 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 |
IYE | K031764 |
| Feb 14, 2018 | Siemens 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 |
IYE | K993425 |
| Feb 14, 2018 | Brainlab 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 |
IYE | K120789 |
| Dec 8, 2017 | Hitachi 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 |
IYE | K072047 K122450 +1 |
| Dec 1, 2017 | Elekta, Inc. ELEKTA Digital Accelerator under the following brand names: Elekta Synergy, Synergy S, Synergy Platform, Precise Digital Accelerator, Infinity, Axesse, and Versa HD Terminated |
IYE | K051932 |
| Nov 20, 2017 | Elekta Limited Integrity R1.2 Terminated |
IYE | K112613 |
| Nov 20, 2017 | Elekta Limited Agility with Integrity R3.2 Terminated |
IYE | K123808 |
| Nov 17, 2017 | Accuray 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 |
IYE | K121934 |
| Nov 17, 2017 | Accuray 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 |
IYE | K121934 |
| Nov 17, 2017 | Accuray 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 |
IYE | K121934 |
| Nov 17, 2017 | Accuray 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 |
IYE | K121934 |
| Nov 3, 2017 | Brainlab 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 |
IYE | K122451 |
| Jun 21, 2017 | Elekta, 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 |
IYE | K123230 |
| Jun 19, 2017 | Elekta, Inc. iGUIDE Software 2.2
Product Usage:
Control of accurate patient positioning with assistance of a 30 Tracking System in a radiotherapy environment. Terminated |
IYE | K143485 |
| May 16, 2017 | Mobius 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 |
IYE | K140660 |
| Apr 26, 2017 | Iba 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 |
IYE | K945321 |
| Feb 14, 2017 | Siemens Medical Solutions USA, Inc ONCOR" Expression
ONCOR" Impression
ONCOR" Impression plus Terminated |
IYE | K060226 |
| Feb 14, 2017 | Siemens Medical Solutions USA, Inc ONCOR" Avant-garde Terminated |
IYE | K031764 |
| Feb 14, 2017 | Siemens Medical Solutions USA, Inc Mevatron M2/Primus Mid-Energy
PRIMUS HI Terminated |
IYE | K993425 |
| Feb 14, 2017 | Siemens Medical Solutions USA, Inc ARTISTE" MV System Terminated |
IYE | K072485 |
| Jan 25, 2017 | Siemens 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 |
IYE | K862339 |
| Jan 25, 2017 | Siemens 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 |
IYE | K882729 |
| Jan 25, 2017 | Siemens 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 |
IYE | K791967 |
| Jan 25, 2017 | Siemens 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 |
IYE | K812032 |
| Jan 25, 2017 | Siemens 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 |
IYE | K790688 |
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