System, Radiation Therapy, Charged-Particle, Medical
Regulation 892.5050
4510(k)s in 12 months (93 all time)
3recalls in 12 months (58 all time)
55recalls that name a 510(k)
Top companies in LHN
| Company | 510(k)s | Recalls |
|---|---|---|
| Ion Beam Applications S.A. | 13 | 35 |
| Mevion Medical Systems | 4 | 10 |
| Varian Medical Systems | 8 | 0 |
| Hitachi , Ltd. | 4 | 0 |
| Hitachi, Ltd., Health Care Company | 4 | 0 |
| Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha | 2 | 2 |
| Anzai Medical Co., Ltd. | 3 | 0 |
| Brainlab AG | 3 | 0 |
| Hitachi America, Ltd., Particle Therapy Division | 0 | 3 |
| Medcom GmbH | 3 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 24, 2009 | K093250 | PROTON THERAPY MULTILEAF COLLIMATOR Varian Medical Systems | LHN |
| Dec 22, 2009 | K092796 | IBA PROTON THERAPY SYSTEM, PROTEUS 235 Ion Beam Applications S.A. | LHN |
| Sep 18, 2009 | K092653 | VERISUITE AND VERISUITE-PARTICLE, VERSION 1.8 Medcom GmbH, DE | LHN |
| Aug 11, 2009 | K091629 | PROTEUS 235 PROTON THERAPY SYSTEM Ion Beam Applications S.A., BE | LHN |
| Apr 15, 2009 | K083058 | IBA PROTON THERAPY SYSTEM - PROTEUS 235 Ion Beam Applications S.A. | LHN |
| Dec 12, 2008 | K082416 | IBA PROTON THERAPY SYSTEM- PROTEUS 235 Ion Beam Applications S.A. | LHN |
| Aug 7, 2008 | K080799 | ATLAS-BASED AUTOSEGMENTATION Computerized Medical Systems, Inc. | LHN |
| Jun 24, 2008 | K080886 | IPLAN RT IMAGE Brainlab AG, DE | LHN |
| Dec 10, 2007 | K073059 | PROBEAT WITH DISCRETE SPOT SCANNING SYSTEM Hitachi, Ltd., Power Systems Group | LHN |
| Jun 20, 2007 | K071399 | DOSE VERIFICATION SYSTEM PATIENT DOSIMETRY SYSTEM, MODEL DVS-I-11: DVS INSERTION TOOL, DVS-D-A: DVS DOSIMETER, DVS-R-100 Sicel Technologies, Inc. | LHN |
| Dec 14, 2006 | K062891 | PROTON THERAPY SYSTEM Indiana University Cyclotron Facility | LHN |
| Jul 28, 2006 | K061913 | IBA PROTON THERAPY SYSTEM - PROTEUS 235 Ion Beam Applications S.A. | LHN |
| Jun 13, 2006 | K061051 | DOSE VERIFICATION SYSTEM PATIENT DOSIMETRY SYSTEM, MODELS DVS-I-11, DVS INSERTION TOOL, DVS-D-A, DVS DOSIMETER Sicel Technologies, Inc. | LHN |
| May 10, 2006 | K061152 | MUCHECK V7.0 Oncology Data Systems, Inc. | LHN |
| Apr 19, 2006 | K060834 | PROBEAT WITH MGCS Hitachi , Ltd. | LHN |
| Apr 11, 2006 | K060695 | IBA PROTON THERAPY SYSTEM - PROTEUS 235 Ion Beam Applications S.A. | LHN |
| Apr 3, 2006 | K052118 | DOSE VERIFICATION SYSTEM Sicel Technologies, Inc. | LHN |
| Mar 9, 2006 | K053280 | PROBEAT Hitachi, Ltd., Power Systems Group | LHN |
| Jan 24, 2006 | K053641 | IBA PROTON THERAPY SYSTEM-PROTEUS 235 Ion Beam Applications S.A. | LHN |
| Jan 21, 2004 | K032511 | INTUITION IMAGE Brainlab AG, DE | LHN |
| Jan 9, 2004 | K032886 | DIAMOND SETUP 2000 K&S Assoc., Inc. | LHN |
| Nov 10, 2003 | K031385 | ANZAI AZ-733 RESPIRATORY GATING SYSTEM Anzai Medical Co., Ltd. | LHN |
| Jul 20, 2001 | K983332 | NORTHEAST PROTON THERAPY CENTER Massachusetts General Hospital | LHN |
| Jul 12, 2001 | K983024 | PROTON THERAPY SYSTEM Ion Beam Applications S.A. | LHN |
| Aug 18, 2000 | K002194 | TREATVISION Varian Medical Systems, Inc. | LHN |
| Jul 21, 2000 | K992414 | PROTON BEAM THERAPY SYSTEM (PBTS) Optivus Technology, Inc. | LHN |
| Jul 14, 1999 | K983660 | EXACTRAC (BRAINLAB PATIENT POSITIONING SYSTEM) Brainlab, Inc. | LHN |
| Jun 8, 1999 | K983629 | RPM RESPIRATORY GATING SYSTEM Varian Medical Systems, Inc. | LHN |
| Mar 5, 1999 | K982952 | IMFAST Siemens Medical Solutions USA, Inc. | LHN |
| Dec 21, 1998 | K983342 | MR GUIDED PROCEDURES (MRGP) BASIC PACKAGE Philips Medical Systems (Cleveland), Inc. | LHN |
| Nov 19, 1998 | K982937 | MODEL 580-006 RADIATION THERAPY IONIZATION CHAMBER Victoreen, Inc. | LHN |
| Jul 24, 1998 | K981112 | MOBETRON Intraop Medical, Inc. | LHN |
| Jul 13, 1998 | K981358 | ARTOSCAN S Biosound Esaote, Inc. | LHN |
| Jun 25, 1998 | K981115 | RADIO-PLAST Smith & Nephew, Inc. | LHN |
| Jan 14, 1998 | K973960 | MODEL 37-185 Victoreen, Inc. | LHN |
| Sep 10, 1997 | K972212 | 0.015CC PINPOINT IONIZATION CHAMBER, 0.005 CC PINPOINT IONIZATION CHAMBER Ptw-New York Corp. | LHN |
| Sep 10, 1997 | K972211 | MULTIDOS, QC6PLUS Ptw-New York Corp. | LHN |
| Mar 7, 1996 | K953391 | TREATMENT MANAGEMENT SYSTEM Siemens Medical Solutions USA, Inc. | LHN |
| Apr 26, 1989 | K891261 | INTRAOPERATIVE RADIATION THERAPY DEVICES General Electric Co. | LHN |
| Mar 20, 1986 | K860606 | RADIACARE INTRAOPERATIVE RADIOTHERAPY SYSTEM Bionix Corp. | LHN |
| Dec 5, 1985 | K853964 | COMPUTERIZED RADIATION TREATMENT PLANNING SYS Computerized Medical Systems, Inc. | LHN |
| Sep 20, 1985 | K851301 | TARGET CAT#B7850AA & B7850AB & B7850B General Electric Co. | LHN |
| Sep 19, 1985 | K852907 | SIEMENS MEVATRON ME Siemens Medical Laboratories, Inc. | LHN |
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