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)
Oct 20, 2010Varian Medical Systems Oncology Systems
Varian brand TrueBeam and TrueBeam STx, Model Number:TMX- H19, Distributed by and Manufactured by: Varian Medical Systems Inc., Palo Alto, CA
Terminated
IYEK092871
Oct 18, 2010Impac Medical Systems Inc
Sequencer Verify & Record System, for use with radiotherapy treatment machines, Class IIb, manufactured by Impac Medical Systems, Sunnyvale, CA.
Terminated
IYEK981313
Sep 1, 2010Elekta, Inc.
Elekta Synergy XVI Intended use: Radiation therapy treatment of malignant neoplastic diseases, as determined by a licensed medical practitioner.
Terminated
IYEK051932
Apr 27, 2010Elekta, Inc.
Elekta Synergy Intended to be used for radiation therapy treatment of malignant neoplastic diseases.
Terminated
IYEK032996
Apr 26, 2010Elekta, Inc.
iView GT Electronic Portal Imaging Device, used with radiation therapy treatments.
Terminated
IYEK981790
Apr 22, 2010Elekta, Inc.
Elekta Synergy XVI The intended use: Radiation therapy treatment of malignant neoplastic diseases, as determined by a licensed medical practitioner.
Terminated
IYEK051932
Apr 16, 2010Elekta, Inc.
Elekta Synergy XVI Medical Linear Accelerator. Model Numbers R3.5, R4.0 and R4.2. Elekta, Inc. Norcross, GA 30092. Intended for use as a radiation therapy treatment of malignant neoplastic diseases,
Terminated
IYEK051932
Mar 18, 2010Elekta, Inc.
Elekta SL Series/Precise Digital Accelerator. The product is used with radiation therapy treatment of malignant neoplastic diseases, as determined by a licensed medical practitioner.
Terminated
IYEK032996
Nov 9, 2009Varian Medical Systems Oncology Systems
VARiS 6.2, 6.1 and 6.0 when used with LINK, Model numbers H88 and H85. Manufactured by Varian Medical Systems, Palo Alto, CA.
Terminated
IYEK001643
Nov 6, 2009Med Tec Inc
CIVCO MTAPSID2932 Type-S Thermoplastic, Disposable nonsterile (48.3 cm) IMRT Style 29 thermoplastic (3.2 mm), Ref. MTAPSID2932, disposable frame mask, 5 per box. The firm name on the label is CIVCO,
Terminated
IYEK933227
Nov 5, 2009Siemens Medical Solutions USA, Inc
Siemens ARTISTE syngo RT Therapist, Therapist Assist, Therapist Express Basic, and Therapist Express Assist Systems, manufactured by Siemens Medical Solutions, Concord, CA
Terminated
IYEK072485
Sep 24, 2009Siemens Medical Solutions USA, Inc
ARTISTE MV Systems (Part Number 8139789), equipped with a syngo RT Therapist (Part Number 8162815) or RT Therapist Assist system (Part Number 8162807), with Software version NET VA10A for RTT4.1.122 o
Terminated
IYEK072485
Sep 14, 2009Accuray Inc
CyberKnife Treatment Delivery System, a subsystem of the CyberKnife Robotic Radiosurgery System, manufactured by Accuray Inc., Sunnyvale, CA. Indicated for treatment for planning and image-guided ste
Terminated
IYEK072504
Aug 27, 2009Varian Medical Systems Oncology Systems
Varis, Aria Radiation Oncology - Version 8.1.15, 8.5.11, and 8.6.07, Model number HIT-INFSYS, Manufactured by Varian Medical Systems Inc., Palo Alto, CA The Varis RV function is designed to assist th
Terminated
IYEK001643
Aug 27, 2009Varian Medical Systems Oncology Systems
Clinac with Version 7.x Software, manufactured by Varian Medical Systems, Palo Alto, CA. Part of the Trilogy Radiotherapy Delivery System for radiation therapy intended to delivery megavoltage x-ray
Terminated
IYEK904364
Aug 21, 2009Impac Medical Systems Inc
SEQUENCER component of MOSAIQ versions 1.30 (all builds), 1.40 (all builds), 1.50 (all builds), 1.60 (all builds), and 2.0 (all builds). Manufactured by IMPAC Medical Systems, Inc. Sunnyvale, CA. Th
Terminated
IYEK981313
Jul 2, 2009Brainlab AG
BrainLAB M3 Micro-Multileaf-Collimator for Elekta/Philips Type III with MLC, model 41600-06, -6 A; BrainLAB AG, Acetylesterase 12, 85622 Edicendi, Germany. The m MLC is intended to assist the radiat
Terminated
IYEK004022
Jul 2, 2009Brainlab AG
BrainLab M3 Micro-Multileaf-Collimator for Siemens Mevatron Digital Type III with MLC, model 41600-5, -5 A; BrainLAB AG, Acetylesterase 12, 85622 Edicendi, Germany. The m MLC is intended to assist th
Terminated
IYEK020860
Jul 2, 2009Brainlab AG
BrainLab m3 Micro-Multileaf-Collimator for Varian Type III with MLC, model 41600-3; BrainLab AG, Kapellenstrasse 12, 85622 Feldkirchen, Germany. The mMLC is intended to assist the radiation oncologis
Terminated
IYEK004022
Jul 2, 2009Brainlab AG
BrainLab Micro-Multileaf-Collimator, model 41600; BrainLab AG, Kapellenstrasse 12, 85622 Feldkirchen, Germany. The mMLC is intended to assist the radiation oncologist in the delivery of radiation to
Terminated
IYEK970586
Feb 20, 2009Varian Medical Systems Oncology Systems
Varian Medical Systems Eclipse treatment planning system, Model Number H48, versions 6.5/7.x and Inspiration 8.0.
Terminated
IYEK010975
Jan 30, 2009Siemens Medical Solutions USA, Inc
Artiste MV Digital Linear Accelerator System Equipped with 160 MCL Accessory Holder, Manufactured by Siemens Medical Solutions, Oncology Care System, Concord, CA Medical charged-particle radiation the
Terminated
IYEK072485
Jan 29, 2009Siemens Medical Solutions USA, Inc
Artiste MV SA Linear Accelerator with syngo RT Therapist Version 4.1 build 67 and build 122. Manufactured by Siemens Medical Solutions Oncology Care Systems, Concord, CA.
Terminated
IYEK072485
Jan 22, 2009TomoTherapy Incorporated
TomoTherapy HI-ART Systems with versions 2.2.4, 3.1.2, 3.1.3 or 3.2.1 software. The affected applications include Planning Station, Planned Adaptive, Data Management System, and TomoPortal. TomoThera
Terminated
IYEK060912
Jan 17, 2009Accuray Inc
Cyberknife Robotic Radiosurgery System. A radiation therapy device, MultiPlan (MP) Treatment Planning Software and Iris Variable Aperture Collimator, Software version 3.0. Product is indicated for t
Terminated
IYEK072504
Jan 14, 2009Siemens Medical Solutions USA, Inc
Artiste MV Digital Linear Accelerator, when used in combination with Syngo RT Therapist Version 4.1 build 67 and automatic Motion of Flat Panel, part number 8139789, manufactured by Siemens Medical S
Terminated
IYEK072485
Jan 5, 2009TomoTherapy Incorporated
TomoTherapy HI-ART Systems with 3.1.2, 3.1.3 or 3.2.1 software. The affected applications include Planning Station, Planned Adaptive, Data Management System, and TomoPortal. The product is intended f
Terminated
IYEK060912
Oct 22, 2008Varian Medical Systems Oncology Systems
Varian RV Software Varian Treatment for Non-Varian Linacs Version 6.6.5042 and 6.6.5043; Model Number: H46; Product is manufactured and distributed by Varian Medical Systems Inc., Palo Alto, CA Desig
Terminated
IYEK001643
Oct 20, 2008Varian Medical Systems Oncology Systems
Exact Couch with Exact Couch Top, a component of the C-Series Clinacs, Acuity and Ximatron treatment systems. Model numbers H14, H18, H27, H72, H77. A powered radiation therapy patient support assemb
Terminated
IYEK033339
K904364
Oct 20, 2008Siemens Medical Solutions USA, Inc
Artiste MV system, Part number 8139789, medical linear accelerator equipped with COHERENCE therapist RTT4.1. Medical Linear accelerator for radiation therapy. The device utilizes a console system for
Terminated
IYEK072485
Oct 16, 2008Siemens Medical Solutions USA, Inc
PRIMEVIEW 3i System 2.1 equipped with a Coherence Therapist R2.0 or R2.1, and PRIMEVIEW 3iR2.0 or R2.1, part number 8147675 Medical charged-particle radiation therapy system.
Terminated
IYEK060226
Oct 16, 2008Siemens Medical Solutions USA, Inc
Coherence Therapist System 2.1 equipped with a Coherence Therapist R2.0 or R2.1, and PRIMEVIEW 3iR2.0 or R2.1, part number 8147667 Medical charged-particle radiation therapy system.
Terminated
IYEK060226
Oct 16, 2008Siemens Medical Solutions USA, Inc
Coherence Therapist 2.0 equipped with a Coherence Therapist R2.0 or R2.1, and PRIMEVIEW 3iR2.0 or R2.1, part number 8139839 Medical charged-particle radiation therapy system.
Terminated
IYEK060226
Oct 16, 2008Siemens Medical Solutions USA, Inc
Syngo Based WS for 3rd party equipped with a Coherence Therapist R2.0 or R2.1, and PRIMEVIEW 3iR2.0 or R2.1, part number 7345437 Medical charged-particle radiation therapy system.
Terminated
IYEK060226
Oct 16, 2008Siemens Medical Solutions USA, Inc
Impression Therapist 3rd party V&R equipped with a Coherence Therapist R2.0 or R2.1, and PRIMEVIEW 3iR2.0 or R2.1, part number 7345429 Medical charged-particle radiation therapy system.
Terminated
IYEK060226
Oct 16, 2008Siemens Medical Solutions USA, Inc
AG Therapist 3rd party V&R equipped with a Coherence Therapist R2.0 or R2.1, and PRIMEVIEW 3iR2.0 or R2.1, part number 7345411 Medical charged-particle radiation therapy system.
Terminated
IYEK060226
Oct 16, 2008Siemens Medical Solutions USA, Inc
PRIMEVIEW 3i System equipped with a Coherence Therapist R2.0 or R2.1, and PRIMEVIEW 3iR2.0 or R2.1, part number 7341428 Medical charged-particle radiation therapy system.
Terminated
IYEK060226
Oct 16, 2008Siemens Medical Solutions USA, Inc
Coherence Impression Therapist System equipped with a Coherence Therapist R2.0 or R2.1, and PRIMEVIEW 3iR2.0 or R2.1, part number 7341410 Medical charged-particle radiation therapy system.
Terminated
IYEK060226
Oct 16, 2008Siemens Medical Solutions USA, Inc
Coherence Therapist System Part number 7339125 Medical charged-particle radiation therapy system.
Terminated
IYEK060226
Oct 16, 2008Siemens Medical Solutions USA, Inc
Coherence AG Therapist Part number 5863506, equipped with a Coherence Therapist R2.0 or R2.1, and PRIMEVIEW 3iR2.0 or R2.1 Medical charged-particle radiation therapy system.
Terminated
IYEK060226
Sep 29, 2008Siemens Medical Solutions USA, Inc
Siemens Medical Solutions, MEVATRON MD-2 part number 9401654 equipped with a Digital Electron Variable Applicator (DEVA, Part Number 8485971) with available energy of 6 MeV.
Terminated
IYEK060226
Sep 29, 2008Siemens Medical Solutions USA, Inc
Siemens Medical Solutions, MEVATRON M2-6740 part number 9401506 equipped with a Digital Electron Variable Applicator (DEVA, Part Number 8485971) with available energy of 6 MeV.
Terminated
IYEK060226
Sep 29, 2008Siemens Medical Solutions USA, Inc
Siemens Medical Solutions, MEVATRON M2-6740 part number 9401407equipped with a Digital Electron Variable Applicator (DEVA, Part Number 8485971) with available energy of 6 MeV.
Terminated
IYEK060226
Sep 29, 2008Siemens Medical Solutions USA, Inc
Siemens Medical Solutions, ONCOR IMPRESSION Plus Digital Linear Accelerator, part number 5857912 equipped with a Digital Electron Variable Applicator (DEVA, Part Number 8485971) with available energy
Terminated
IYEK060226
Sep 29, 2008Siemens Medical Solutions USA, Inc
Siemens Medical Solutions, PRIMUS Plus Digital Linear Accelerator, part number 4504200 equipped with a Digital Electron Variable Applicator (DEVA, Part Number 8485971) with available energy of 6 MeV.
Terminated
IYEK993425
Sep 29, 2008Siemens Medical Solutions USA, Inc
Siemens Medical Solutions, Mevatron M2/ Primus Mid Digital Linear Accelerator, part number 1940035 equipped with a Digital Electron Variable Applicator (DEVA, Part Number 8485971) with available energ
Terminated
IYEK862339
Sep 29, 2008Siemens Medical Solutions USA, Inc
Siemens Medical Solutions, Mevatron KD2 Digital Linear Accelerator, part number 1940753 equipped with a Digital Electron Variable Applicator (DEVA, Part Number 8485971) with available energy of 6 MeV.
Terminated
IYEK862339
Sep 29, 2008Siemens Medical Solutions USA, Inc
Siemens Medical Solutions, Mevatron KDS-2 Digital Linear Accelerator, part number 9822693 equipped with a Digital Electron Variable Applicator (DEVA, Part Number 8485971) with available energy of 6 Me
Terminated
IYEK862339
Sep 29, 2008Siemens Medical Solutions USA, Inc
Siemens Medical Solutions, Mevatron KD-2 Digital Linear Accelerator, part number 9822685 equipped with a Digital Electron Variable Applicator (DEVA, Part Number 8485971) with available energy of 6 MeV
Terminated
IYEK862339
Sep 29, 2008Siemens Medical Solutions USA, Inc
Siemens Medical Solutions, Mevatron KDS-2 Digital Linear Accelerator, part number 9411588 equipped with a Digital Electron Variable Applicator (DEVA, Part Number 8485971) with available energy of 6 Me
Terminated
IYEK862339

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