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 |
|---|---|---|---|
| Feb 4, 1997 | K964485 | PORTPRO ELECTRONIC PORTAL IMAGING SYSTEM Eliav , Ltd., IL | IYE |
| Jan 3, 1997 | K961400 | RFA-300, LDA UTILITY Scanditronix Medical AB | IYE |
| Dec 23, 1996 | K963860 | THE NOMOS TALON POSITIONING AND IMMOBILIZATION SYSTEM Nomos Corp. | IYE |
| Dec 6, 1996 | K963624 | PHILIPS SLI SERIES LINEAR ACCELERATOR Philips Medical Systems, Inc. | IYE |
| Nov 18, 1996 | K963258 | PEACOCK SYSTEM Nomos Corp. | IYE |
| Nov 12, 1996 | K962792 | LINAC SCALPEL TREATMENT PLANNING SYSTEM Surgical Navigation Technologies, Inc. | IYE |
| Nov 8, 1996 | K954679 | THERAPLAN PLUS Theratronics, Inc., CA | IYE |
| Nov 7, 1996 | K961484 | CASS SYSTEM (MODIFICATION) Medical Instrumentation & Diagnostics Corp.(Midco) | IYE |
| Sep 9, 1996 | K962487 | BREAST TREATMENT AID M200 S. and H. Engineering, Inc. | IYE |
| Aug 23, 1996 | K962080 | RPS-50 BEAM SCANNER Sofield Science Services, Inc. | IYE |
| Aug 22, 1996 | K962155 | GILL-THOMAS-COSMAN(GTC) DENTAL TRAY Radionics Software Applications, Inc. | IYE |
| Aug 9, 1996 | K961467 | HEAD RETAINING DEVICE S. and H. Engineering, Inc. | IYE |
| Aug 6, 1996 | K961214 | MULTI LEAF COLLIMATOR Mitsubishi Intl. Corp. | IYE |
| Aug 5, 1996 | K954861 | BRAINLAB CT/X-RAY LOCALIZER Brainlab Med. Computersysteme GmbH, DE | IYE |
| Aug 1, 1996 | K960293 | MRTOFLM COMPUTER PROGRAM Northwest Medical Physics Equipment, Inc. | IYE |
| Jun 19, 1996 | K961170 | BREAST TREATMENT AID S. and H. Engineering, Inc. | IYE |
| Jun 17, 1996 | K961208 | 0.6CC IONIZATION CHAMBER - WATERPROOF 0.6CC IONIZATION CHAMBER Ptw-New York Corp. | IYE |
| May 28, 1996 | K960834 | KODAK EC-L CASSETTE Eastman Kodak Company | IYE |
| Apr 23, 1996 | K960338 | STEREOTACTIC BODY FRAME Elekta Instrument AB | IYE |
| Apr 22, 1996 | K960510 | THERAVIEW Infimed, Inc. | IYE |
| Apr 22, 1996 | K954564 | PID-1 PRECISION INTELLIGENT DOSIMETER Gammex, Inc. | IYE |
| Apr 9, 1996 | K940663 | PEACOCK PLAN Nomos Corp. | IYE |
| Apr 8, 1996 | K951581 | PINNACLE3 APEX Adac Laboratories | IYE |
| Mar 15, 1996 | K955774 | VARIS PORTALVISION Varian Assoc., Inc. | IYE |
| Feb 26, 1996 | K953508 | COMPUTE-RX PLAN PC3D Medicalibration Physics Consultant Services, Inc. | IYE |
| Feb 2, 1996 | K943224 | VARIAN MULTILEAF COLLIMATOR Varian Assoc., Inc. | IYE |
| Jan 17, 1996 | K952314 | EXL-12SP & 12DP LINAC Mitsubishi Intl. Corp. | IYE |
| Jan 5, 1996 | K954705 | ACRYSTEEL BLOCKING TRAY Medtec, Inc. | IYE |
| Dec 22, 1995 | K954634 | RADIOSURGERY VERIFICATION PHANTOM The Phantom Laboratory, Inc. | IYE |
| Dec 21, 1995 | K952108 | EXL-15DP & 20-DP LINAC Mitsubishi Intl. Corp. | IYE |
| Dec 21, 1995 | K946074 | ALDERSON BREST DOSIMETRY SYSTEM Radiology Support Devices, Inc. | IYE |
| Dec 5, 1995 | K954165 | PTW-MP3 & PTW-MP3S AUTOMATIC WATER PHANTOM Ptw-New York Corp. | IYE |
| Nov 14, 1995 | K940001 | PLATO-SRS(STEREO RADIOSURGERY TREATMENT PLANNING SYS) Nucletron Corp. | IYE |
| Oct 25, 1995 | K953570 | PHILIPS MULTI LEAF PRESCRIPTION ENTRY SYSTEM (MLP) Philips Medical Systems, Inc. | IYE |
| Oct 25, 1995 | K953482 | XKNIFE-3 Radionics Software Applications, Inc. | IYE |
| Oct 7, 1995 | K951764 | UNIDOS UNIVERSAL DOSIMETER MODEL 10002-WITH TNC CONNECTOR, 10005-WITH BNT CONNECTOR Ptw-New York Corp. | IYE |
| Sep 22, 1995 | K953046 | PERI-PUSHER Diacor, Inc. | IYE |
| Sep 15, 1995 | K952729 | PAINTED WEDGE & ROD BREAST BOARD Medtec, Inc. | IYE |
| Aug 25, 1995 | K941118 | HEAD IMMOBILIZATION APPARATUS Northwest Medical Physics Center | IYE |
| Aug 23, 1995 | K952457 | RAPID-FOAM The Soule Co., Inc. | IYE |
| Aug 16, 1995 | K950061 | HERCULES RADIATION THERAPY COUCH Precision Therapy Intl., Inc. | IYE |
| Aug 9, 1995 | K952189 | MED-TEC REDISET Medtec, Inc. | IYE |
| Jul 21, 1995 | K944040 | PLANET THERMOPLASTIC IMMOBILIZATION SYSTEM S & S X-Ray Products, Inc. | IYE |
| Jul 13, 1995 | K950075 | MED-TEC TRAY ADAPTER Medtec, Inc. | IYE |
| Jul 12, 1995 | K951947 | MED-TEC RADIO THERAPY TREATMENT CHAIR Medtec, Inc. | IYE |
| Jul 12, 1995 | K951679 | MED-TEC TESTICULAR SEPARATOR Medtec, Inc. | IYE |
| Jul 12, 1995 | K945321 | WELLHOFER WP700 V. 3.2 Medical Physics Instrumentation, Inc. | IYE |
| Jul 6, 1995 | K951808 | MED-TEC REDI-FOAM Medtec, Inc. | IYE |
| Jun 28, 1995 | K951717 | MED-TEC KNEE CRUTCH Medtec, Inc. | IYE |
| Jun 19, 1995 | K951143 | PULSE KLYSTRON AMPLIFIFER (L-5822-90) Litton Systems, Inc. | IYE |
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