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) |
|---|---|---|---|
| Feb 7, 2007 | Elekta, Inc. Desktop Pro R6.0 & R6.1, Linear Medical Accelerator. Terminated |
IYE | K982713 |
| Dec 19, 2006 | Varian Medical Systems Inc 4D Integrated Treatment Console and Varis 1.4g Medical Charged Particle Radiation Therapy System;
All 4D Integrated treatment console versions 8.0.15 and below (excluding v7.0.31) and all Varis Non-V Terminated |
IYE | K001643 K050479 |
| Nov 16, 2006 | Varian Medical Systems Inc Clinac High Energy Medical Linear Accelerator, Medical Charged-particle radiation therapy system; Model #s: 2100(C,C/D EX) and 2300 C, C/D EX) Terminated |
IYE | K904264 K913119 |
| Aug 11, 2006 | Siemens Medical Solutions USA, Inc LANTIS XLINK (Impac MultiAccess Sequencer) on Varian accelerators with the MLC3PI interface Terminated |
IYE | K981313 |
| Aug 5, 2006 | Varian Medical Systems Oncology Systems Varis Vision Treatment 6.6/RTP Exchange/Siemens Accelerators Terminated |
IYE | K050479 |
| Jul 6, 2006 | Varian Medical Systems Inc Varian brand Clinac C-series Pendant Radiation delivery system. All model numbers included. Model numbers 2100, 2100C/D, 21 EX. 2300 C/D, 23 EX, 600C, 600 C/D, 2500 C, Trilogy, 6EX and Silhouette. Terminated |
IYE | K862645 |
| Jan 7, 2006 | Siemens Medical Solutions USA, Inc LANTIS software with MedOnc Module;
MedOnc module is an option of the LANTIS radiotherapy treatment planning software distributed as a component of the firm''s linear accelerator used to deliver radi Terminated |
IYE | K981313 |
| Jan 6, 2006 | Siemens Medical Solutions USA, Inc Siemens brand PRIMUS Linear Accelerators equipped with the optional Retractable Beam Shield and MEVATRON Linear Accelerator with optinal Retractable Beam Shield. Terminated |
IYE | K993425 |
| Sep 9, 2005 | Varian Medical Systems Inc Clinac (linear accelerator); Model 21EXS Silhouette Machine (slim version of the Clinac);
Distributed by and/or Manufactured by: Varian Medical Systems, Palo Alto, CA 94304. Terminated |
IYE | K904364 K913119 |
| Apr 27, 2005 | Varian Medical Systems Inc Varian brand Clinac 600C (CD, EX) and Portal Vison with Dynamic MLC or RPM system capability Terminated |
IYE | K862645 K904364 +1 |
| Jul 20, 2004 | Varian Medical Systems Inc Linear accelerator workstation software suite Terminated |
IYE | K990085 |
| Jun 27, 2003 | Standard Imaging Inc. Exradin A12 Ionization Chamber Terminated |
IYE | None listed |
| Mar 12, 2003 | Varian Medical Systems Inc VARiS 1.4G and Vision/SomaVision Radiation Therapy Systems; VARiS versions 6.1.33 and 6.2.19 in conjunction with Eclipse 6.x/Soma Vision 6.x Terminated |
IYE | K001643 |
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