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 |
|---|---|---|---|
| Mar 16, 1987 | K864910 | MEVACHECK Magus Microcontrollers, Inc., CA | IYE |
| Jan 6, 1987 | K863705 | COMPUTER CONTROLLED EXTENSION (CCX) Varian Assoc., Inc. | IYE |
| Oct 29, 1986 | K862339 | MEVATRON KD-2 Siemens Medical Laboratories, Inc. | IYE |
| Oct 3, 1986 | K862645 | CLINAC (R) C SERIES (400C, 600C, 2100C, 2500C) Varian Assoc., Inc. | IYE |
| Sep 19, 1986 | K863358 | VARIAN RMS-2000 Varian Assoc., Inc. | IYE |
| Aug 26, 1986 | K862065 | PC-PLAN Dosimetrix, Inc. | IYE |
| Feb 6, 1986 | K852609 | MEVASSIST(SETUP CONTROLLER) Magus Microcontrollers, Inc., CA | IYE |
| Jul 18, 1985 | K851041 | ADAC MODELS XL-PLAN 23 & XL-PLAN 73 Adac Laboratories | IYE |
| Mar 16, 1984 | K840136 | LINEAR ACCELERATOR MULTIPLE EXL 3-4-6 Adac Laboratories | IYE |
| Dec 29, 1983 | K833941 | ORION Cgr Medical Corp. | IYE |
| Sep 29, 1983 | K832732 | RADIOTHERAPY MGMT. SYSTEM RMS-1000 Varian Assoc., Inc. | IYE |
| Sep 12, 1983 | K832503 | CLINAC 1800 Varian Assoc., Inc. | IYE |
| Sep 12, 1983 | K832502 | ELECTRON BEAM OPTION FOR CLINAC 15 MEV Varian Assoc., Inc. | IYE |
| Sep 12, 1983 | K832216 | VARIAN CLINACOMP 100 TISSUE COMPENSATOR Varian Assoc., Inc. | IYE |
| Jun 24, 1983 | K837347 | LINEAR ACCELERATOR THERAC 25 Atomic Energy of Canada, CA | IYE |
| Mar 31, 1982 | K820448 | ARS-1000 Applied Radiation | IYE |
| Mar 31, 1982 | K820310 | DELTA PLAN II RADIATION THERAPY PLAN Technicare Corp. | IYE |
| Aug 18, 1981 | K812032 | MEVATRON 67E Siemens Medical Laboratories, Inc. | IYE |
| Jan 7, 1981 | K802809 | ELECTRON ARC THERAPY Varian Assoc., Inc. | IYE |
| Jan 7, 1981 | K802808 | 6MV PORT FILM CAPABILITY OPTION Varian Assoc., Inc. | IYE |
| May 14, 1980 | K800792 | ADJUSTABLE HEAD & FACE HOLDER Radiation Products Design, Inc. | IYE |
| May 14, 1980 | K800791 | MYLAR WINDOW-TABLE INSERT PANEL Radiation Products Design, Inc. | IYE |
| May 14, 1980 | K800790 | TENNIS RACKET-TABLE INSERT PANEL Radiation Products Design, Inc. | IYE |
| May 14, 1980 | K800761 | POINT TO POINT LEVEL Radiation Products Design, Inc. | IYE |
| May 14, 1980 | K800759 | ELEV. BACK SUPPORT W/ADJ. ARM POSITIONER Radiation Products Design, Inc. | IYE |
| Nov 16, 1979 | K791967 | MEVATRON 74X MEDICAL LINEAR ACCELERATOR Siemens Medical Laboratories, Inc. | IYE |
| May 4, 1979 | K790747 | MEVATRON 74 Siemens Medical Laboratories, Inc. | IYE |
| Apr 23, 1979 | K790688 | MEVATRON 67 Siemens Medical Laboratories, Inc. | IYE |
| Mar 26, 1979 | K790388 | MEVATRON 60 Siemens Medical Laboratories, Inc. | IYE |
| Nov 27, 1978 | K781872 | CLINAC 2500 Varian Assoc., Inc. | IYE |
| Sep 14, 1978 | K781174 | CLINAC 12/10 Varian Assoc., Inc. | IYE |
| Jul 17, 1978 | K781057 | CLINAC 20 (OPTIONAL 18 MV VERSION) Varian Assoc., Inc. | IYE |
| Jan 26, 1978 | K780027 | ACCELERATOR, LINEAR, MED. Emi Therapy Systems, Inc. | IYE |
| Oct 19, 1977 | K771902 | EMI FOUR Emi Therapy Systems, Inc. | IYE |
| Oct 19, 1977 | K771809 | CLINAC 6/100 Varian Assoc., Inc. | IYE |
| Oct 19, 1977 | K771808 | CLINAC 4/100 Varian Assoc., Inc. | IYE |
| Aug 16, 1977 | K771358 | CLINAC 20 Varian Assoc., Inc. | IYE |
| Aug 3, 1977 | K771260 | LINEAR ACCELERATOR G-2900 Atomic Energy of Canada | IYE |
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