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 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 17, 1993 | K924240 | PROWESS 2000 Small Systems Group, Inc. | IYE |
| Apr 7, 1993 | K924632 | LCM-2-LINAC COUCH-MOUNT SYSTEM Radionics, Inc. | IYE |
| Apr 7, 1993 | K921740 | COMPUTER ASSISTED STEREOTACTIC SURGERY -- MODIFIED Medical Instrumentation & Diagnostics Corp.(Midco) | IYE |
| Dec 29, 1992 | K920879 | BRAINSCAN RADIOSURGERY MODULE Brainlab, DE | IYE |
| Nov 27, 1992 | K921991 | PLATO RADIATION THERAPY PLANNING SYSTEM Nucletron-Oldelft Corp. | IYE |
| Oct 15, 1992 | K911973 | LINEAR ACCELERATOR COLLIMATOR Medical Equipment Development Co., Inc. | IYE |
| Jun 5, 1992 | K914698 | SETUP COMPUTER WITH SOFTWARE V-1261,62 AND 63 K.S., Inc. | IYE |
| Mar 31, 1992 | K920455 | THERAVIEW DIGITAL PORTAL IMAGING COMPUTER (MOD.) S & S Inficon, Inc. | IYE |
| Mar 30, 1992 | K920041 | ADAC XL-PLAN-PC Adac Laboratories | IYE |
| Dec 19, 1991 | K913612 | SEQUENCER Impac Medical Systems, Inc. | IYE |
| Nov 22, 1991 | K913674 | RECORD AND VERIFY MEVATRON ADAPTER Computerized Medical Systems, Inc. | IYE |
| Nov 7, 1991 | K913119 | VARIAN C-SERIES CLINACS (CLINAC 2300C/D) Varian Assoc., Inc. | IYE |
| Nov 5, 1991 | K913174 | VARIAN CLINAC 600SR Varian Assoc., Inc. | IYE |
| Nov 4, 1991 | K912630 | XKNIFE RADIOSURGERY SYSTEM Rsa, Inc. | IYE |
| Oct 15, 1991 | K911750 | COMPUTER ASSIST STEREOTACTIC SURG SYST, MODIFIED Medical Instrumentation & Diagnostics Corp.(Midco) | IYE |
| Jun 13, 1991 | K911612 | NUCLETRON PLANNING SYSTEM Nucletron-Oldelft Corp. | IYE |
| Jun 6, 1991 | K904908 | STEREOTACTIC IRRADIATION SYSTEM Northwest Medical Physics Center | IYE |
| May 3, 1991 | K901932 | VARIAN ELECTRONIC PORTAL IMAGING SYSTEM Varian Assoc., Inc. | IYE |
| Feb 27, 1991 | K904364 | VARIAN C-SERIES CLINACS CLINAC 600C,2100C,2500C Varian Assoc., Inc. | IYE |
| Feb 12, 1991 | K905007 | STANDARD BREAST BOARDS; DELUXE BREAST BOARD Bionix Development Corp. | IYE |
| Nov 7, 1990 | K903139 | BEAMVIEW & BEAMVIEW PLUS (AKA PROJECT 743) Siemens Medical Laboratories, Inc. | IYE |
| Oct 23, 1990 | K900434 | MM-22 MICROTRON, MM50 MICROTRON Scanditronix, Inc. | IYE |
| Aug 23, 1990 | K902339 | THERAVIEW DIGITAL PORTAL IMAGING COMPUTER S & S Inficon, Inc. | IYE |
| Aug 3, 1990 | K902849 | PHILIPS VERIFLEX Philips Medical Systems, Inc., NL | IYE |
| Mar 23, 1990 | K892425 | STP COMPLETE MODULE SET Leibinger & Fischer , Ltd. | IYE |
| Jan 12, 1990 | K895697 | VAC FIX(R) SYSTEM S&S Par Scientific | IYE |
| Jan 3, 1990 | K894722 | RENNER-PLAN W.D. Renner Consulting Co. | IYE |
| Nov 21, 1989 | K895733 | FIBERVISION(TM) Fiber Imaging, Inc. | IYE |
| Nov 6, 1989 | K895500 | PATIENT POSITIONING ACCESSORIES Perkins Mfg. Co. | IYE |
| Oct 13, 1989 | K894912 | SRI 100 RADIOTHERAPY IMAGING SYSTEM Philips Medical Systems, Inc., NL | IYE |
| Oct 11, 1989 | K894706 | HT-RES RTP SYSTEM Adac Laboratories | IYE |
| Sep 18, 1989 | K891292 | SRS-200 RADIOSURGERY SYSTEM Philips Medical Systems North America, Inc. | IYE |
| Sep 1, 1989 | K893978 | MEDISYS RECORD AND VERIFY SYSTEM Medisys, Inc. | IYE |
| Aug 28, 1989 | K894230 | PATIENT DATA MANAGEMENT SYSTEM (PROJECT 735) Siemens Medical Laboratories, Inc. | IYE |
| Aug 28, 1989 | K894123 | VERICORD S3 Philips Medical Systems, Inc., NL | IYE |
| Jul 20, 1989 | K892845 | SOFTWARE RELEASE 1.3 FOR THE SL SERIES LINEAR ACCE Philips Medical Systems, Inc., NL | IYE |
| Jun 23, 1989 | K892860 | SATURNE 41 General Electric Co. | IYE |
| Nov 10, 1988 | K883019 | SATURNE 42 AND 43 General Electric Co. | IYE |
| Oct 11, 1988 | K883264 | SL SERIES ACCELERATORS SL15, SL18, SL20 & SL25 Philips Medical Systems, Inc., NL | IYE |
| Oct 7, 1988 | K883101 | DVS (OPTION 01) O.M.I. Oncology Microsystems, Inc., CA | IYE |
| Sep 30, 1988 | K883067 | MODIFIED SL-SERIES LINEAR ACCELERATORS Philips Medical Systems, Inc., NL | IYE |
| Sep 22, 1988 | K882231 | SL SERIES, SL 15, 18, 20 & 25 (MODIFICATION) Philips Medical Systems, Inc., NL | IYE |
| Sep 19, 1988 | K882729 | MEVATRON, M 2 CLASS Siemens Medical Laboratories, Inc. | IYE |
| Sep 19, 1988 | K882326 | VARIAN CLINAC 1800S Varian Assoc., Inc. | IYE |
| Aug 4, 1988 | K880200 | EXL-14 MEDICAL LINEAR ACCELERATOR Mitsubishi Intl. Corp. | IYE |
| May 2, 1988 | K874558 | SL SERIES, SL 15, 18, 20 & 25 Philips Medical Systems, Inc., NL | IYE |
| Apr 29, 1988 | K873398 | EXL-22DP X-RAY RADIATION THERAPY SYSTEM Mitsubishi Intl. Corp. | IYE |
| Feb 17, 1988 | K874893 | MODEL 35300 TRACKER(TM) THERAPY BEAM EVALUATOR Keithley Instruments, Inc. | IYE |
| May 8, 1987 | K871214 | GRATICULE Mick Radio-Nuclear Instruments, Inc. | IYE |
| Apr 1, 1987 | K870525 | PHILIPS MODEL SL75-10 LINEAR ACCELERATOR Industrial Accelerator Co. | IYE |
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