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) |
|---|---|---|---|
| Apr 2, 2008 | Siemens Medical Solutions USA, Inc Mevatron M2/PRIMUS MID Medical Linear Accelerator, Material Number: 019490035, with control console software versions 6.5/7.2, 8.0, 9.0 and 9.1, Manufactured by Siemens Medical Solutions USA, Inc, Con Terminated |
IYE | None listed |
| Feb 19, 2008 | Siemens Medical Solutions USA, Inc Siemens Mevatron Linear Accelerator Systems; Mevatron M 7440, Part No.: 5672977; Mevatron M 6700, Part No.: 5693908; Mevatron M 6730, Part No.: 5694005; Mevatron M 7140, Part No.: 5694104; Mevatron Terminated |
IYE | K882729 |
| Feb 19, 2008 | Siemens Medical Solutions USA, Inc Siemens Mevatron Linear Accelerator Systems: KD2, K 7767, K 8067, KD, KDS and KDS2, Mevatron KD2, Part No.: 1940753; Mevatron KD2, Part No.: 08515520; Mevatron KD2-Part No.: 9822685; Mevatron K 7767, Terminated |
IYE | K862339 |
| Feb 19, 2008 | Siemens Medical Solutions USA, Inc Siemens Primus Linear Accelerator System, PRIMART MX Linear Accelerator System; PRIMUS Mid, Part Number:1940035 and PRIMART MX, Part Number: 5500371, Siemens Medical Solutions USA, Inc., Concord, CA Terminated |
IYE | K993425 |
| Feb 15, 2008 | Varian Medical Systems Inc Varian brand VARiS 1.4g (Medical Charged Particle Radiation Therapy System, Record and Verify System); Linear Accelerator with RTP Exchange v6.2, v6.6, & v8.0, All Models; Varian Medical Systems, Palo Terminated |
IYE | K001643 |
| Feb 14, 2008 | Siemens Medical Solutions USA, Inc Siemens Mevatron M-2 PRIMUS hi-energy Medical Charged-Particle Radiation Therapy System; (Interlock #51 Jaw Field Position) Model Number 4504200, Siemens Medical Solutions, Concord, CA 94520 Terminated |
IYE | K993425 |
| Feb 14, 2008 | Siemens Medical Solutions USA, Inc Siemens Mevatron M-2 PRIMUS mid-energy Medical Charged-Particle Radiation Therapy System; (Interlock #51 Jaw Field Position) Model Number :1940035, Siemens Medical Solutions, Concord, CA 94520 Terminated |
IYE | K993425 |
| Feb 14, 2008 | Siemens Medical Solutions USA, Inc Siemens Mevatron K-2 Medical Charged-Particle Radiation Therapy System; (Interlock #51 Jaw Field Position) Model Number: 1940753, Siemens Medical Solutions, Concord, CA 94520 Terminated |
IYE | K862339 |
| Feb 14, 2008 | Siemens Medical Solutions USA, Inc Seimens Mevatron M-2 6300 Medical Charged-Particle Radiation Therapy System; (Interlock #51 Jaw Field Position) Model Number: 9401316, Siemens Medical Solutions, Concord, CA 94520 Terminated |
IYE | K882729 |
| Feb 14, 2008 | Siemens Medical Solutions USA, Inc Seimens Mevatron M-2 6700 Medical Charged-Particle Radiation Therapy System; (Interlock #51 Jaw Field Position) Model Number 9401407, Siemens Medical Solutions, Concord, CA 94520 Terminated |
IYE | K882729 |
| Feb 14, 2008 | Siemens Medical Solutions USA, Inc Siemens Mevatron MDX-2 Medical Charged-Particle Radiation Therapy System; (Interlock #51 Jaw Field Position) Model number 9401746, Siemens Medical Solutions, Concord, CA 94520 Terminated |
IYE | K882729 |
| Feb 14, 2008 | Siemens Medical Solutions USA, Inc Seimens Mevatron KD-2 Medical Charged-Particle Radiation Therapy System; (Interlock #51 Jaw Field Position) Model Number: 9822685, Siemens Medical Solutions, Concord, CA 94520 Terminated |
IYE | K862339 |
| Feb 14, 2008 | Siemens Medical Solutions USA, Inc Siemens Mevatron KDS-2 Medical Charged-Particle Radiation Therapy System; (Interlock #51 Jaw Field Position) Model Number 9822693 and 9411588, Siemens Medical Solutions, Concord, CA 94520 Terminated |
IYE | K862339 |
| Feb 14, 2008 | Siemens Medical Solutions USA, Inc Siemens Mevatron M-2 6740 Medical Charged-Particle Radiation Therapy System; (Interlock #51 Jaw Field Position)Model Number: 9401506, Siemens Medical Solutions, Concord, CA 94520 Terminated |
IYE | K882729 |
| Feb 14, 2008 | Siemens Medical Solutions USA, Inc Siemens Mevatron MD2 Medical Charged-Particle Radiation Therapy System; (Interlock #51 Jaw Field Position) Model Number: 09401654, Siemens Medical Solutions, Concord, CA 94520 Terminated |
IYE | K882729 |
| Feb 14, 2008 | Siemens Medical Solutions USA, Inc Siemens Mevatron KD2 Medical Charged-Particle Radiation Therapy System; (Interlock #51 Jaw Field Position) Model Number:08515520, Siemens Medical Solutions, Concord, CA 94520 Terminated |
IYE | K862339 |
| Feb 14, 2008 | Varian Medical Systems Inc Varian brand Clinac, Accelerator, Linear, Medical charged-particle radiation therapy system;
Model: Low Energy Clinacs with one or more of the following options:
-- BrainLAB micro MLC
-- Stereotacti Terminated |
IYE | K070094 |
| Feb 14, 2008 | Varian Medical Systems Inc Varian brand Clinac, Accelerator, Linear, Medical charged-particle radiation therapy system: Model: High Energy Clinacs with one or more of the following options:
-- BrainLAB micro MLC,
-- 6MV SRS ph Terminated |
IYE | K070094 |
| Jan 29, 2008 | Varian Medical Systems Inc Varian Real-Time Position Management System (RPM), A Respiratory Gating System; Version 1.7.3, All Models; Varian Medical Systems, Palo Alto, CA 94304 Terminated |
IYE | K063270 |
| Dec 1, 2007 | Siemens Medical Solutions USA, Inc Siemens, Mevatron M2 Primus, Part No.: 19 40 035, Mid-Energy Medical Charge particle radiation therapy system, with pre-R2.0 Optivue Flat Panel Positioners, Siemens Medical, Concord, CA 94520 Terminated |
IYE | None listed |
| Dec 1, 2007 | Siemens Medical Solutions USA, Inc Siemens, ONCOR Avante Garde, Part No.: 58 63 472,Medical Charge particle radiation therapy system, with pre-R2.0 Optivue Flat Panel Positioners, Siemens Medical, Concord, CA 94520 Terminated |
IYE | None listed |
| Dec 1, 2007 | Siemens Medical Solutions USA, Inc Siemens, Oncor Impression, Part No.: 58 57 920, Medical Charge particle radiation therapy system,with pre-R2.0 Optivue Flat Panel Positioners, Siemens Medical, Concord, CA 94520 Terminated |
IYE | None listed |
| Dec 1, 2007 | Siemens Medical Solutions USA, Inc Siemens, Oncor Impression Plus, Part No.: 58 57 912, Medical Charge particle radiation therapy system,with pre-R2.0 Optivue Flat Panel Positioners, Siemens Medical, Concord, CA 94520 Terminated |
IYE | None listed |
| Dec 1, 2007 | Siemens Medical Solutions USA, Inc Siemens, Mevatron M2/PRIMUS Plus, Part No.: 45 04 200, High EnergyMedical Charge particle radiation therapy system with pre-R2.0 Optivue Flat Panel Positioners, Siemens Medical, Concord, CA 94520 Terminated |
IYE | K031764 K993425 |
| Nov 9, 2007 | Siemens Medical Solutions USA, Inc PRIMUS Plus,Medical charge-particle radiation therapy system (Medical Digital Linear Accelerator),MODEL NUMBER: 4504200,MANUFACTURED BY: Siemens Medical Solutions USA, Inc, 4040 Nelson Ave, Concord, Terminated |
IYE | K993425 |
| Nov 9, 2007 | Siemens Medical Solutions USA, Inc MEVATRON M2/PRIMUS Mid,Medical charge-particle radiation therapy system (Medical Digital Linear Accelerator),MODEL NUMBER: 1940035, MANUFACTURED BY: Siemens Medical Solutions USA, Inc, 4040 Nelson Av Terminated |
IYE | K993425 |
| Nov 9, 2007 | Siemens Medical Solutions USA, Inc ONCOR IMPRESSION,Medical charge-particle radiation therapy system (Medical Digital Linear Accelerator),MODEL NUMBER: 5857920, MANUFACTURED BY: Siemens Medical Solutions USA, Inc, 4040 Nelson Ave, Con Terminated |
IYE | K993425 |
| Nov 9, 2007 | Siemens Medical Solutions USA, Inc ONCOR IMPRESSION Plus,Medical charge-particle radiation therapy system (Medical Digital Linear Accelerator),MODEL NUMBER: 5857912, MANUFACTURED BY: Siemens Medical Solutions USA, Inc, 4040 Nelson Ave Terminated |
IYE | K993425 |
| Nov 9, 2007 | Siemens Medical Solutions USA, Inc ONCOR Expression,Medical charge-particle radiation therapy system (Medical Digital Linear Accelerator),MODEL NUMBERS: 7360204 and 7360717, MANUFACTURED BY: Siemens Medical Solutions USA, Inc, 4040 Ne Terminated |
IYE | K060226 |
| Nov 9, 2007 | Siemens Medical Solutions USA, Inc ONCOR Avant Garde,Medical charge-particle radiation therapy system (Medical Digital Linear Accelerator),MODEL NUMBER: 5863472,MANUFACTURED BY: Siemens Medical Solutions USA, Inc, 4040 Nelson Ave, Con Terminated |
IYE | K031764 |
| Nov 9, 2007 | Siemens Medical Solutions USA, Inc MEVATRON MDX-2,Medical charge-particle radiation therapy system (Medical Digital Linear Accelerator),MODEL NUMBER: 9401746,MANUFACTURED BY: Siemens Medical Solutions USA, Inc, 4040 Nelson Ave, Concor Terminated |
IYE | K882729 |
| Nov 9, 2007 | Siemens Medical Solutions USA, Inc MEVATRON MD-2,Medical charge-particle radiation therapy system (Medical Digital Linear Accelerator),MODEL NUMBER: 9401654,MANUFACTURED BY: Siemens Medical Solutions USA, Inc, 4040 Nelson Ave, Concord Terminated |
IYE | K882729 |
| Nov 9, 2007 | Siemens Medical Solutions USA, Inc MEVATRON M-2 6740,Medical charge-particle radiation therapy system (Medical Digital Linear Accelerator),MODEL NUMBER: 9401506,MANUFACTURED BY: Siemens Medical Solutions USA, Inc, 4040 Nelson Ave, Con Terminated |
IYE | K882729 |
| Nov 9, 2007 | Siemens Medical Solutions USA, Inc MEVATRON M-2 6700,Medical charge-particle radiation therapy system (Medical Digital Linear Accelerator),MODEL NUMBER: 9401407,MANUFACTURED BY: Siemens Medical Solutions USA, Inc, 4040 Nelson Ave, Con Terminated |
IYE | K882729 |
| Nov 9, 2007 | Siemens Medical Solutions USA, Inc MEVATRON M-2 6300,Medical charge-particle radiation therapy system (Medical Digital Linear Accelerator),MODEL NUMBER: 9401316,MANUFACTURED BY: Siemens Medical Solutions USA, Inc, 4040 Nelson Ave, Con Terminated |
IYE | K882729 |
| Nov 9, 2007 | Siemens Medical Solutions USA, Inc MEVATRON KDS-2,Medical charge-particle radiation therapy system (Medical Digital Linear Accelerator),MODEL NUMBERS: 9411588 and 9822693,MANUFACTURED BY: Siemens Medical Solutions USA, Inc, 4040 Nelso Terminated |
IYE | K882729 |
| Nov 9, 2007 | Siemens Medical Solutions USA, Inc MEVATRON KDS,Medical charge-particle radiation therapy system (Medical Digital Linear Accelerator),MODEL NUMBER: 9401522, MANUFACTURED BY: Siemens Medical Solutions USA, Inc, 4040 Nelson Ave, Concord Terminated |
IYE | K882729 |
| Nov 9, 2007 | Siemens Medical Solutions USA, Inc MEVATRON KD-2,Medical charge-particle radiation therapy system (Medical Digital Linear Accelerator), MODEL NUMBERS: 8515520 and 9822685, MANUFACTURED BY: Siemens Medical Solutions USA, Inc, 4040 Nels Terminated |
IYE | K882729 |
| Nov 9, 2007 | Siemens Medical Solutions USA, Inc MEVATRON KD2,Medical charge-particle radiation therapy system (Medical Digital Linear Accelerator),MODEL NUMBER: 1940753, MANUFACTURED BY: Siemens Medical Solutions USA, Inc, 4040 Nelson Ave, Concord Terminated |
IYE | K882729 |
| Aug 29, 2007 | Varian Medical Systems Inc Varian On-Board Imager Device versions 1.2 and 1.3, when used with Cone Beam Computed Tomography. Medical Linear Accelerator. Terminated |
IYE | K040192 K041519 +1 |
| Aug 9, 2007 | Northwest Medical Physics Equipment Inc ISOLOC Software Version 4.2, Part Number NT-NW-425-520. Image guided radiation treatment software. Terminated |
IYE | K904908 |
| Aug 8, 2007 | Northwest Medical Physics Equipment Inc ISOLOC Software Version 6.0, Part Number NT-NW-425-520. Localization software for radiotherapy treatment system. Terminated |
IYE | K904908 |
| Aug 8, 2007 | Northwest Medical Physics Equipment Inc ISOLOC Software Version 6.0, Localization software for determining treatment machine position (to position patients) for high accuracy radiotherapy. Terminated |
IYE | K904908 |
| Aug 8, 2007 | Northwest Medical Physics Equipment Inc ISOLOC Software Versions 6.0 and 4.2. Part Number NT-NW-425-520. Image guided radiotherapy treatment software. Terminated |
IYE | K904908 |
| Aug 8, 2007 | Northwest Medical Physics Equipment Inc ISOLOC 4.2 Software Part Number NT-NW-425-520. Image guided radiation treatment software. Terminated |
IYE | K904908 |
| Aug 8, 2007 | Northwest Medical Physics Equipment Inc ISOLOC 6.5 Software Part Number NT-NW-425-520. Software for radiotherapy treatment. Terminated |
IYE | K904908 |
| Aug 8, 2007 | Northwest Medical Physics Equipment Inc Isoloc software Versions 6.5 and 4.5, Part Number NT-NW-425-520. Software for image guided radiation therapy. Terminated |
IYE | K904908 |
| Jul 12, 2007 | Varian Medical Systems Inc Varian Medical Systems Clinac Medical Linear Accelerator. Clinac 600 C &C/D, Clinac 2100 C, C/D & EX and Clinac 2300 C &C/D Terminated |
IYE | K862645 K913119 |
| Jun 28, 2007 | Varian Medical Systems Inc LINAC Scapel Treatment Planning System, incorporating FastPlan software versions 4.0, 5.0, 5.0.1, 5.1, 5.1.1. Terminated |
IYE | None listed |
| Jun 6, 2007 | Varian Medical Systems Oncology Systems FramelessArray software, Version 1.0. ; Medical Device firmware incorporated with the RadioCamera Extracranial System, distributed by Varian Medical System, Palo Alto, CA. Terminated |
IYE | None listed |
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