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) |
|---|---|---|---|
| Oct 20, 2010 | Varian 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 |
IYE | K092871 |
| Oct 18, 2010 | Impac Medical Systems Inc Sequencer Verify & Record System, for use with radiotherapy treatment machines, Class IIb, manufactured by Impac Medical Systems, Sunnyvale, CA. Terminated |
IYE | K981313 |
| Sep 1, 2010 | Elekta, Inc. Elekta Synergy XVI
Intended use: Radiation therapy treatment of malignant neoplastic diseases, as determined by a licensed medical practitioner. Terminated |
IYE | K051932 |
| Apr 27, 2010 | Elekta, Inc. Elekta Synergy
Intended to be used for radiation therapy treatment of malignant neoplastic diseases. Terminated |
IYE | K032996 |
| Apr 26, 2010 | Elekta, Inc. iView GT Electronic Portal Imaging Device, used with radiation therapy treatments. Terminated |
IYE | K981790 |
| Apr 22, 2010 | Elekta, Inc. Elekta Synergy XVI
The intended use: Radiation therapy treatment of malignant neoplastic diseases, as determined by a licensed medical practitioner. Terminated |
IYE | K051932 |
| Apr 16, 2010 | Elekta, 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 |
IYE | K051932 |
| Mar 18, 2010 | Elekta, 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 |
IYE | K032996 |
| Nov 9, 2009 | Varian 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 |
IYE | K001643 |
| Nov 6, 2009 | Med 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 |
IYE | K933227 |
| Nov 5, 2009 | Siemens 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 |
IYE | K072485 |
| Sep 24, 2009 | Siemens 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 |
IYE | K072485 |
| Sep 14, 2009 | Accuray 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 |
IYE | K072504 |
| Aug 27, 2009 | Varian 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 |
IYE | K001643 |
| Aug 27, 2009 | Varian 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 |
IYE | K904364 |
| Aug 21, 2009 | Impac 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 |
IYE | K981313 |
| Jul 2, 2009 | Brainlab 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 |
IYE | K004022 |
| Jul 2, 2009 | Brainlab 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 |
IYE | K020860 |
| Jul 2, 2009 | Brainlab 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 |
IYE | K004022 |
| Jul 2, 2009 | Brainlab 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 |
IYE | K970586 |
| Feb 20, 2009 | Varian Medical Systems Oncology Systems Varian Medical Systems Eclipse treatment planning system, Model Number H48, versions 6.5/7.x and Inspiration 8.0. Terminated |
IYE | K010975 |
| Jan 30, 2009 | Siemens 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 |
IYE | K072485 |
| Jan 29, 2009 | Siemens 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 |
IYE | K072485 |
| Jan 22, 2009 | TomoTherapy 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 |
IYE | K060912 |
| Jan 17, 2009 | Accuray 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 |
IYE | K072504 |
| Jan 14, 2009 | Siemens 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 |
IYE | K072485 |
| Jan 5, 2009 | TomoTherapy 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 |
IYE | K060912 |
| Oct 22, 2008 | Varian 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 |
IYE | K001643 |
| Oct 20, 2008 | Varian 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 |
IYE | K033339 K904364 |
| Oct 20, 2008 | Siemens 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 |
IYE | K072485 |
| Oct 16, 2008 | Siemens 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 |
IYE | K060226 |
| Oct 16, 2008 | Siemens 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 |
IYE | K060226 |
| Oct 16, 2008 | Siemens 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 |
IYE | K060226 |
| Oct 16, 2008 | Siemens 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 |
IYE | K060226 |
| Oct 16, 2008 | Siemens 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 |
IYE | K060226 |
| Oct 16, 2008 | Siemens 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 |
IYE | K060226 |
| Oct 16, 2008 | Siemens 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 |
IYE | K060226 |
| Oct 16, 2008 | Siemens 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 |
IYE | K060226 |
| Oct 16, 2008 | Siemens Medical Solutions USA, Inc Coherence Therapist System Part number 7339125
Medical charged-particle radiation therapy system. Terminated |
IYE | K060226 |
| Oct 16, 2008 | Siemens 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 |
IYE | K060226 |
| Sep 29, 2008 | Siemens 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 |
IYE | K060226 |
| Sep 29, 2008 | Siemens 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 |
IYE | K060226 |
| Sep 29, 2008 | Siemens 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 |
IYE | K060226 |
| Sep 29, 2008 | Siemens 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 |
IYE | K060226 |
| Sep 29, 2008 | Siemens 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 |
IYE | K993425 |
| Sep 29, 2008 | Siemens 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 |
IYE | K862339 |
| Sep 29, 2008 | Siemens 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 |
IYE | K862339 |
| Sep 29, 2008 | Siemens 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 |
IYE | K862339 |
| Sep 29, 2008 | Siemens 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 |
IYE | K862339 |
| Sep 29, 2008 | Siemens 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 |
IYE | K862339 |
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