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) |
|---|---|---|---|
| Jan 25, 2017 | Siemens 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 |
IYE | K993425 |
| Jan 25, 2017 | Siemens 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 |
IYE | K993425 |
| Jan 25, 2017 | Siemens 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 |
IYE | K060226 |
| Jan 25, 2017 | Siemens 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 |
IYE | K031764 |
| Jan 25, 2017 | Siemens 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 |
IYE | K072485 |
| Jan 10, 2017 | Varian 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 |
IYE | K141283 |
| Dec 21, 2016 | Accuray 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 |
IYE | K011024 |
| Dec 12, 2016 | Accuray 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 |
IYE | K122137 |
| Dec 2, 2016 | Elekta, 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 |
IYE | K141572 |
| Oct 13, 2016 | Varian 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 |
IYE | K142560 |
| Aug 30, 2016 | Elekta, 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 |
IYE | K072079 |
| Jul 26, 2016 | Siemens 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 |
IYE | K090683 |
| Jul 26, 2016 | Siemens 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 |
IYE | K993425 |
| Jul 26, 2016 | Siemens 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 |
IYE | K103606 |
| Jul 15, 2016 | Elekta, Inc. MOSAIQ Oncology Information System Open, Classified |
IYE | K123230 |
| Jul 11, 2016 | Varian 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 |
IYE | K123371 |
| Jul 11, 2016 | Varian 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 |
IYE | K123371 |
| Jul 8, 2016 | Elekta, Inc. Medical Linear Accelerator Terminated |
IYE | K051932 |
| Jun 30, 2016 | Vision 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 |
IYE | K140528 |
| Jun 30, 2016 | Vision 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 |
IYE | K123371 |
| Jun 17, 2016 | Elekta, Inc. MOSAIQ Oncology Information System Terminated |
IYE | K141572 |
| May 23, 2016 | Elekta, Inc. iGUIDE System, for patient positioning, with assistance of a 30 Tracking System in a radiotherapy environment. Terminated |
IYE | K072079 |
| May 4, 2016 | Brainlab AG ExacTrac Vero is a Patient Positioning System for Radiation therapy. Terminated |
IYE | K122451 |
| Mar 31, 2016 | Viewray 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 |
IYE | K111862 |
| Mar 31, 2016 | MITSUBISHI 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 |
IYE | K072047 K122450 +1 |
| Mar 25, 2016 | Wfr/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 |
IYE | K090349 |
| Mar 24, 2016 | MITSUBISHI 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 |
IYE | K072047 K122450 +1 |
| Feb 12, 2016 | Viewray Incorporated MRIdian ViewRay Radiation Therapy System, VIEWRAY Inc. Terminated |
IYE | K111862 |
| Feb 9, 2016 | Accuray 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 |
IYE | K120233 |
| Feb 2, 2016 | Philips Medical Systems DS/US Proton Feature with Pinnacle3 Software Version 10.0.0 and 14.0.0 Radiation Therapy Planning System Model #459800200621 Terminated |
IYE | K130992 |
| Jan 21, 2016 | Iba Dosimetry Gmbh IBA Dosimetry GmbH Lift Table Type 4320, Catalog HA03-010#2 and HA03-000#2 Terminated |
IYE | K945321 |
| Dec 9, 2015 | Elekta, 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 |
IYE | K141572 |
| Nov 24, 2015 | Elekta, Inc. MOSAIQ Oncology Information System.
Used to manage workflows for treatment planning and delivery. Terminated |
IYE | K141572 |
| Oct 27, 2015 | Siemens 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 |
IYE | K031764 K060226 +2 |
| Oct 9, 2015 | Viewray 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 |
IYE | K111862 |
| Oct 6, 2015 | Siemens 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 |
IYE | K142434 |
| Sep 24, 2015 | Siemens 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 |
IYE | K031764 K060226 +3 |
| Aug 21, 2015 | Brainlab 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 |
IYE | K120789 |
| Aug 21, 2015 | PTW-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 |
IYE | K951764 |
| Jul 16, 2015 | Viewray 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 |
IYE | K111862 |
| Jul 14, 2015 | Elekta, 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 |
IYE | K141572 |
| Jul 2, 2015 | Viewray 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 |
IYE | K111862 |
| May 5, 2015 | Viewray Incorporated ViewRay System, Radiation Therapy System Terminated |
IYE | K111862 |
| May 1, 2015 | MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MACHINERY WORK MHI-TM2000 Linear Accelerator System (Software Version 3.5.0 and 3.5.1) Terminated |
IYE | K072047 K122450 |
| Mar 25, 2015 | Brainlab AG ExacTrac versions 6.x patient positioning systems are used to position patients during radiosurgery or radiotherapy procedures.. Terminated |
IYE | K120789 |
| Mar 18, 2015 | Siemens 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 |
IYE | K060226 |
| Mar 16, 2015 | Siemens 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 |
IYE | K972275 |
| Feb 26, 2015 | Iba Dosimetry Gmbh COMPASS SW Version 3.1, Catalog Number CS10-100, medical linear accelerator, radiological Terminated |
IYE | K072374 |
| Feb 10, 2015 | Elekta, Inc. Precise Digital Accelerator
Intended to be used for radiation therapy treatments of malignant neoplastic diseases, as determined by a licensed medical practitioner. Terminated |
IYE | K051932 |
| Feb 5, 2015 | Siemens 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 |
IYE | K031764 K060226 +3 |
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