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 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 12, 2014 | Mevion Medical Systems, Inc. MEVION S250, used for proton radiation therapy. Terminated |
LHN | K120676 |
| Jun 21, 2014 | VARIAN MEDICAL SYSTEMS PARTICLE THERAPY GMBH ProBeam Proton Therapy System (HGA and HFB)
Product Usage:ProBeam Proton Therapy System provides protons for precision radiotherapy of lesions, tumors, and conditions anywhere in the body. where radi Terminated |
LHN | K133191 |
| Apr 24, 2014 | Ion Beam Applications S.A. Proteus 235 Proton Therapy System Legacy Software version 7.2.7 and higher, models 110, 112, 113, and 116.
Proton therapy Terminated |
LHN | K082416 |
| Mar 22, 2014 | Mevion Medical Systems, Inc. MEVION S250, System, Radiation Therapy, Charged-Particle, Medical used for Proton Radiation Therapy
Product Usage: Proton Radiation Therapy Terminated |
LHN | K120676 |
| Oct 3, 2008 | Intraop Medical Corporation Mobetron Model 1000, mobile electron linear accelerator, a device system which delivers radiation to an intraoperative site. Terminated |
LHN | K981112 |
| Jul 24, 2008 | Hitachi Medical Systems America Inc EUB-5500 VISION 5500 Diagnostic Ultrasound Scanner w/Step 5 (V05-7) Software. Imaging device intended to provide the physician with physiological and clinical information. Terminated |
LHN | None listed |
| Dec 13, 2007 | Mizuho Orthopedic Systems Inc OSI, 6822 IntraOp Series Tables, Operating Room tables, Orthopedic Systems, Inc., Union City, CA. (Series 6800 and 6822 included) Terminated |
LHN | None listed |
| Dec 13, 2007 | Mizuho Orthopedic Systems Inc OSI, Allegro 6800 Imaging Table (Operating), single pedestal AC or battery operated table, Orthopedic Systems, Inc., Union City, CA Terminated |
LHN | None listed |
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