| Device Type ID | 5381 |
| Device Name | System, Radiation Therapy, Charged-particle, Medical |
| Regulation Description | Medical Charged-particle Radiation Therapy System. |
| Regulation Medical Specialty | Radiology |
| Review Panel | Radiology |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR) |
| Submission Type | 510(k) |
| CFR Regulation Number | 892.5050 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | LHN |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Expansion Pilot Program |
| Device Type ID | 5381 |
| Device | System, Radiation Therapy, Charged-particle, Medical |
| Product Code | LHN |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Medical Charged-particle Radiation Therapy System. |
| CFR Regulation Number | 892.5050 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
ANZAI MEDICAL CO, LTD. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
HITACHI, LTD. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ION BEAM APPLICATIONS S.A. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
MEDCOM GMBH | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
MEVION MEDICAL SYSTEMS | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
PRONOVA SOLUTIONS, LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
PROTOM INTERNATIONAL, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SUMITOMO HEAVY INDUSTRIES, LTD | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
VARIAN | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
VARIAN MEDICAL SYSTEMS, INC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Malposition Of Device | 5 |
Positioning Problem | 2 |
Component Falling | 2 |
Computer Software Problem | 2 |
Detachment Of Device Component | 2 |
Failure To Auto Stop | 2 |
No Apparent Adverse Event | 1 |
Unexpected Therapeutic Results | 1 |
Device Operates Differently Than Expected | 1 |
Device Operational Issue | 1 |
Human-Device Interface Problem | 1 |
Use Of Incorrect Control Settings | 1 |
Human Factors Issue | 1 |
Protective Measures Problem | 1 |
Fluid Leak | 1 |
| Total Device Problems | 24 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Elekta, Inc. | II | Sep-06-2017 |
| 2 | Hitachi America, Ltd., Power Systems Division | II | Jul-18-2015 |
| 3 | Ion Beam Applications S.A. | II | Jan-08-2019 |
| 4 | Ion Beam Applications S.A. | II | Oct-11-2018 |
| 5 | Ion Beam Applications S.A. | II | Jul-17-2018 |
| 6 | Ion Beam Applications S.A. | II | Jun-23-2018 |
| 7 | Ion Beam Applications S.A. | II | Jun-20-2018 |
| 8 | Ion Beam Applications S.A. | II | Jun-12-2018 |
| 9 | Ion Beam Applications S.A. | II | Jun-08-2018 |
| 10 | Ion Beam Applications S.A. | II | Jun-07-2018 |
| 11 | Ion Beam Applications S.A. | II | Mar-09-2018 |
| 12 | Ion Beam Applications S.A. | II | Mar-09-2018 |
| 13 | Ion Beam Applications S.A. | II | Mar-09-2018 |
| 14 | Ion Beam Applications S.A. | II | Mar-08-2018 |
| 15 | Ion Beam Applications S.A. | II | Mar-08-2018 |
| 16 | Ion Beam Applications S.A. | II | Jul-04-2017 |
| 17 | Ion Beam Applications S.A. | II | Jul-03-2017 |
| 18 | Ion Beam Applications S.A. | II | Jun-19-2017 |
| 19 | Ion Beam Applications S.A. | II | May-03-2017 |
| 20 | Ion Beam Applications S.A. | II | Apr-17-2017 |
| 21 | Ion Beam Applications S.A. | II | Mar-23-2017 |
| 22 | Ion Beam Applications S.A. | II | Dec-19-2014 |
| 23 | Ion Beam Applications S.A. | II | Apr-24-2014 |
| 24 | Mevion Medical Systems, Inc. | II | Jan-09-2019 |
| 25 | Mevion Medical Systems, Inc. | II | Aug-11-2018 |
| 26 | Mevion Medical Systems, Inc. | II | Feb-02-2017 |
| 27 | Mevion Medical Systems, Inc. | II | Apr-20-2016 |
| 28 | Mevion Medical Systems, Inc. | II | Feb-08-2016 |
| 29 | Mevion Medical Systems, Inc. | II | Dec-12-2014 |
| 30 | Mevion Medical Systems, Inc. | II | Mar-22-2014 |
| 31 | VARIAN MEDICAL SYSTEMS PARTICLE THERAPY GMBH | II | Jun-21-2014 |