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 |
|---|---|---|---|
| Nov 2, 1998 | K982713 | RT DESKTOP Elekta Oncology Systems, Ltd. | IYE |
| Oct 26, 1998 | K982624 | MOLDCARE HEAD & NECK CUSHION, MODEL # MT-ACL-14242 Med-Tec,Inc. | IYE |
| Oct 9, 1998 | K981597 | RADIONICS SLICE EDITOR IMAGING SOFTWARE UTILITY Radionics, Inc. | IYE |
| Sep 30, 1998 | K982463 | EXTRACRANIAL RADIOTHERAPY SYSTEM Howmedica, Inc. | IYE |
| Sep 29, 1998 | K981055 | XKNIFE-4 Radionics, Inc. | IYE |
| Aug 7, 1998 | K981790 | IVIEW ELECTRONIC PORTAL IMAGING DEVICE (EPID) MODEL NUMBER IVEW Elekta Oncology Systems, Ltd. | IYE |
| Jul 31, 1998 | K982513 | MX MEVATRON Siemens Medical Solutions USA, Inc. | IYE |
| Jul 31, 1998 | K982502 | GENESIS IMRT LINEAR ACCELERATOR Siemens Medical Solutions USA, Inc. | IYE |
| Jul 17, 1998 | K981424 | NOMOS BAT ULTRASOUND LOCALIZATION AND POSITIONING SYSTEM Nomos Corp. | IYE |
| Jul 10, 1998 | K981346 | RADIOCAMERAS BITEBLOCK LOCALIZATION AND POSITIONING SYSTEM Surgical Navigation Technologies, Inc. | IYE |
| Jul 9, 1998 | K981313 | SEQUENCER Impac Medical Systems, Inc. | IYE |
| Jun 8, 1998 | K980904 | MUCHECK MONITOR UNIT VALIDATION PROGRAM Medical Dosimetry Services, Inc. | IYE |
| Jun 1, 1998 | K980826 | EQUIDOSE SOLID STATE DIODE DETECTORS Cii Mastek, Inc. | IYE |
| Jun 1, 1998 | K973936 | FOCUS RTP SYSTEM Computerized Medical Systems, Inc. | IYE |
| May 20, 1998 | K980750 | RADIOCAMERAS PATIENT POSITIONING SYSTEM Surgical Navigation Technologies, Inc. | IYE |
| May 18, 1998 | K980379 | PROWESS PRO-SIM Ssgi Prowess Systems | IYE |
| May 6, 1998 | K980629 | VSS, VIRTUAL SIMULATION SYSTEM Nucletron Corp. | IYE |
| Apr 24, 1998 | K980402 | CAPINTEC MODEL 292 ELECTROMETER Capintec, Inc. | IYE |
| Mar 10, 1998 | K974703 | CARBON FIBER BREAST BOARD Medtec, Inc. | IYE |
| Mar 4, 1998 | K974700 | MATRIX MT-MX3 Medtec, Inc. | IYE |
| Feb 6, 1998 | K974310 | NOMOS SLIT COLLIMATOR (BEAK) Nomos Corp. | IYE |
| Jan 23, 1998 | K972816 | ADVANCED TREATMENT PLANNING SYSTEM Advanced Radiation Therapy Systems, Inc. | IYE |
| Jan 22, 1998 | K972451 | COREGISTRATION FUNCTION Nomos Corp. | IYE |
| Jan 14, 1998 | K973963 | 120 LEAF MULTILEAF COLLIMATOR Mitsubishi Electronics America, Inc. | IYE |
| Dec 17, 1997 | K973540 | ELEKTA ONCOLOGY SYSTEMS ICOM/QUICKMODE SOFTWARE OPTIONS Elekta Oncology Systems, Inc. | IYE |
| Nov 21, 1997 | K973889 | VARIAN MULTILEAF COLLIMATOR WITH DYNAMIC ARC THERAPY FEATURE Varian Medical Systems, Inc. | IYE |
| Nov 13, 1997 | K971893 | SNT LINAC ACCESSORIES Surgical Navigation Technologies, Inc. | IYE |
| Oct 28, 1997 | K972905 | XPLAN-1 Radionics Software Applications, Inc. | IYE |
| Oct 27, 1997 | K971367 | BRAINSCAN CONFORMAL RT MODULE Brainlab AG, DE | IYE |
| Oct 23, 1997 | K972804 | BANG POLYMER GEL DOSIMETER, BANG 533 Mgs Research, Inc. | IYE |
| Oct 16, 1997 | K972709 | TBI STAND Mick Radio-Nuclear Instruments, Inc. | IYE |
| Oct 1, 1997 | K972617 | HELAX-VISIR Helax AB, SE | IYE |
| Sep 8, 1997 | K972275 | LANTIS TREATSTATION Siemens Medical Solutions USA, Inc. | IYE |
| Sep 5, 1997 | K970464 | P REFERENCE TPS (TREATMENT PLANNING SOFTWARE) 1.1 Northwest Medical Physics Equipment, Inc. | IYE |
| Aug 5, 1997 | K963451 | ANTI-TUMOR EXPERT SYSTEM (ATES) FOR RADIATION THERAPY TREATMENT PLANNING Topslane | IYE |
| Jul 29, 1997 | K970384 | VELOS CONSTANCY CHECK DEVICE, MODEL 55-145 Aktina Medical Physics Corp. | IYE |
| Jul 23, 1997 | K965010 | TARGET 2 VERSION 1.1 GE Medical Systems | IYE |
| Jul 22, 1997 | K962950 | CADPLAN, VERSION 2.62. RADIATION THERAPY TREATMENT PLANNING SYSTEM Varian Medical Systems, Inc. | IYE |
| Jul 9, 1997 | K970236 | THERAPLAN PLUS VERSION 1.2 Theratronics, Inc., CA | IYE |
| Jun 20, 1997 | K964206 | NUCLETRON PLATO EXTERNAL BEAM PLANNING RTS V2 AND RTS 3D V2 Nucletron Corp. | IYE |
| Jun 13, 1997 | K964785 | VERIDOSE DIODES Victoreen, Inc. | IYE |
| Jun 6, 1997 | K971382 | PRONE BREAST POSITIONING BOARD, MODEL #37-018 Victoreen, Inc. | IYE |
| May 12, 1997 | K970586 | BRAINLAB MICRO MULTI-LEAF COLLIMATOR Brainlab Med. Computersysteme GmbH, DE | IYE |
| May 12, 1997 | K970564 | DYNAMIC WEDGE Mitsubishi Electronics America, Inc. | IYE |
| Apr 24, 1997 | K970291 | ACCESSORIES TO THE STEREOTACTIC BODY FRAM Elekta Instrument AB, SE | IYE |
| Apr 15, 1997 | K970137 | EXL-12SP,12DP,15DP,20DP LINAC Mitsubishi Electronics America, Inc. | IYE |
| Apr 1, 1997 | K964517 | LINAC SCALPEL FLOORSTAND Surgical Navigation Technologies, Inc. | IYE |
| Mar 21, 1997 | K964167 | DECISION SUPPORT SYSTEM (FOR RADIATION ONCOLOGY) Multidata Systems International Corp. | IYE |
| Feb 11, 1997 | K964840 | BEAM BLOCK TRAYS Aktina Medical Physics Corp. | IYE |
| Feb 6, 1997 | K962335 | MLC FIT Impac Medical Systems, Inc. | IYE |
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