S-250 PROTON BEAM RADIATION THERAPY SYSTEM
FDA 510(k) clearance K120676 · decided 2012-06-04
Clearance details
- K-number
- K120676
- Device name
- S-250 PROTON BEAM RADIATION THERAPY SYSTEM
- Applicant
- Mevion Medical Systems
- Decision
- Substantially Equivalent
- Date received
- 2012-03-05
- Decision date
- 2012-06-04
- Days to decision
- 91 days
- Clearance type
- Traditional
- Product code
- LHN
- Device class
- 2
- Regulation number
- 892.5050
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Littleton, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| MEVION S250-Proton Radiation Therapy Product Usage: Proton Radiation Therapy recall (Z-1122-2017) | Mevion Medical Systems, Inc. | 2017-02-02 |
| MEVION S250 Product Usage: Proton Radiation Therapy recall (Z-0409-2017) | Mevion Medical Systems, Inc. | 2016-11-15 |
| MEVION S250 Product Usage: Proton Radiation Therapy System recall (Z-0410-2017) | Mevion Medical Systems, Inc. | 2016-11-15 |
| MEVION S250 Product Usage: Proton Radiation Therapy System recall (Z-0411-2017) | Mevion Medical Systems, Inc. | 2016-11-15 |
| MEVION S250 for Proton Radiation Therapy recall (Z-1529-2016) | Mevion Medical Systems, Inc. | 2016-04-20 |
| MEVION S250 Radiation therapy system recall (Z-0767-2016) | Mevion Medical Systems, Inc. | 2016-02-08 |
| MEVION S250, used for proton radiation therapy. recall (Z-0588-2015) | Mevion Medical Systems, Inc. | 2014-12-12 |
| MEVION S250, System, Radiation Therapy, Charged-Particle, Medical used for Proton Radiatio recall (Z-1271-2014) | Mevion Medical Systems, Inc. | 2014-03-22 |