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 |
|---|---|---|---|
| Jun 16, 1995 | K951142 | PULSE KLYSTRON AMPLIFIER (L-5822-00) Litton Systems, Inc. | IYE |
| Jun 9, 1995 | K935615 | MEDICAL LINEAR ACCELERATOR Accelerator Systems Intl., Inc. | IYE |
| Jun 5, 1995 | K945903 | BRAINLAB MASK SYSTEM Brainlab Med. Computersysteme GmbH, DE | IYE |
| May 30, 1995 | K950866 | HIP FIXATION SYSTEM Medtec, Inc. | IYE |
| May 15, 1995 | K942346 | IMAGERT Impac Medical Systems, Inc. | IYE |
| May 12, 1995 | K943714 | MICRO MULTILEAF COLLIMATOR Leibinger F.L. Fischer | IYE |
| May 5, 1995 | K926449 | VARIAN MULTILEAF COLLIMATOR, RELEASE 4.0 Varian Assoc., Inc. | IYE |
| Feb 16, 1995 | K933117 | IORT SYSTEM Northwest Medical Physics Center | IYE |
| Feb 8, 1995 | K934523 | GILL-THOMAS-COSMAN (GTC) RELOCATABLE HEAD HOLDER SYSTEM WITH DEPTH CONFIRMATION HELMET(DH-1) Radionics, Inc. | IYE |
| Feb 1, 1995 | K943464 | PHILIPS IMPROVED CHECK RADIOGRAPH OPTION Philips Medical Systems North America, Inc. | IYE |
| Jan 24, 1995 | K940145 | COMPU-CUTTER THERAPEUTIC SHIELDING CUTTING DEVICE Huestis Machine Corp. | IYE |
| Dec 15, 1994 | K943406 | RF DRIVER, RADIO FREQUENCY DRIVER Pro-Comm, Inc. | IYE |
| Dec 9, 1994 | K940660 | MODEL 37-720 DUAL DIODE DOSIMETRY SYSTEM Victoreen, Inc. | IYE |
| Dec 7, 1994 | K943199 | MOTORIZED DEPTH DOSE APPARATUS Medtec, Inc. | IYE |
| Nov 22, 1994 | K944315 | BLOCKING TRAY Medtec, Inc. | IYE |
| Oct 4, 1994 | K926008 | PINNACLE 3 Adac Laboratories | IYE |
| Sep 23, 1994 | K932501 | VARIAN ORIGAMI, VERSION 1.0 Varian Assoc., Inc. | IYE |
| Sep 23, 1994 | K930513 | VARIAN RMS-2000, RELEASE 2.5 Varian Assoc., Inc. | IYE |
| Sep 16, 1994 | K924685 | STP COMPLETE MODULE SET AND MASK FIXATION SYSTEM Leibinger GmbH | IYE |
| Sep 2, 1994 | K942083 | ADVANCED THERAPY DOSIMETER Keithley Instruments, Inc. | IYE |
| Aug 29, 1994 | K930506 | THERPAC RADIOTHERAPY TREATMENT PLANNING SYSTEM Pinecliff Assoc. | IYE |
| Aug 9, 1994 | K934303 | RFA A-300 Scanditronix, Inc., SE | IYE |
| Aug 9, 1994 | K926321 | VARIAN C/D-SERIES CLINACS (CLINAC 600 C/D) Varian Assoc., Inc. | IYE |
| Jul 29, 1994 | K942092 | DPD-3 Scanditronix, Inc., SE | IYE |
| Jul 29, 1994 | K935928 | RIT 113 FILM ANALYSIS SYSTEM Radiological Imaging Technology, Inc. | IYE |
| Jul 29, 1994 | K935435 | NUCLEAR ASSOC 37-08 SER, RAYCAST HP RADIO IMMOB SYST Victoreen, Inc. | IYE |
| Jul 26, 1994 | K940237 | THERAPLAN V05B/ TP-11 V09B Theratronics, Inc., CA | IYE |
| Jul 22, 1994 | K934657 | BRAINLAB LINAC HARDWARE Brainlab Med. Computersysteme GmbH | IYE |
| Jul 18, 1994 | K942282 | MED-TEC BREAST SUPPORT SYSTEM Medtec, Inc. | IYE |
| Jul 18, 1994 | K935412 | MED-TEC, INC. BREAST BOARD, MT-200 Medtec, Inc. | IYE |
| Jul 18, 1994 | K935411 | MED-TEC, INC. BREAST BOARD, MT-250 Medtec, Inc. | IYE |
| Jul 18, 1994 | K935300 | VAC-LOK IMMOBILIZATION SYSTEM Medtec, Inc. | IYE |
| Jul 18, 1994 | K933227 | UNI-FRAME HEAD IMMOBILIZATION SYSTEM Medtec, Inc. | IYE |
| Jun 3, 1994 | K932598 | TN-RD-50 Keithley Instruments, Inc. | IYE |
| May 26, 1994 | K935067 | AQUAPLAST Wfr/Aquaplast Corp. | IYE |
| May 25, 1994 | K922276 | THERAC 25 Theratronics, Inc., CA | IYE |
| Apr 15, 1994 | K926187 | POSICAST IMMOBILIZATION SYSTEM Huestis Machine Corp. | IYE |
| Apr 7, 1994 | K935021 | HANDI-FOAM Medtec, Inc. | IYE |
| Mar 16, 1994 | K933558 | ARM RADIATION BEAM SCANNER Advanced Radiation Measurements, Inc. | IYE |
| Jan 5, 1994 | K930182 | RADIATION TREATMENT FOR CANCER PATIENTS Northwest Medical Physics Center | IYE |
| Nov 15, 1993 | K931927 | VICTOREEN MODEL 530 Victoreen, Inc. | IYE |
| Nov 3, 1993 | K934566 | RADASSIST Diacor, Inc. | IYE |
| Nov 3, 1993 | K933493 | RAM-PACS Medical Knowledge Systems, Inc. | IYE |
| Oct 7, 1993 | K933614 | PITUITARY BOARD Bionix Development Corp. | IYE |
| Oct 7, 1993 | K933613 | 3-WAY HEAD IMMOBILIZER; 3WAY DELUXE REUSABLE FRAME HEAD IMMOBILIZER Bionix Development Corp. | IYE |
| Aug 18, 1993 | K923522 | LINAC-BASED STEROTACTIC RADIOSURGERY Radionics Software Applications, Inc. | IYE |
| Jul 27, 1993 | K930279 | REFIX(TM) SYSTEM Nomos Corp. | IYE |
| Jul 26, 1993 | K930246 | MAMMORX Diacor, Inc. | IYE |
| Jun 8, 1993 | K925714 | BREAST SIMULATION SYSTEM Severn Research, Inc. | IYE |
| Jun 8, 1993 | K924495 | PHILIPS RTNET RADIOTHERAPY NETWORKING SYSTEM Philips Medical Systems, Inc., NL | IYE |
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