| Device Type ID | 5359 |
| Device Name | Couch, Radiation Therapy, Powered |
| Regulation Description | Powered Radiation Therapy Patient Support Assembly. |
| 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 | 892.5770 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | JAI |
| 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 | 5359 |
| Device | Couch, Radiation Therapy, Powered |
| Product Code | JAI |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Powered Radiation Therapy Patient Support Assembly. |
| CFR Regulation Number | 892.5770 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
FORTE AUTOMATION SYSTEMS, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Application Program Problem | 3 |
Computer Software Problem | 3 |
Device Operates Differently Than Expected | 3 |
Programming Issue | 1 |
Device Stops Intermittently | 1 |
Use Of Device Problem | 1 |
Output Problem | 1 |
| Total Device Problems | 13 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Elekta, Inc. | II | Jul-24-2018 |
| 2 | Elekta, Inc. | II | Mar-19-2015 |
| 3 | Elekta, Inc. | II | Apr-25-2014 |
| 4 | Forte Automation Systems Inc | II | Jul-25-2018 |
| 5 | Med Tec Inc | II | Feb-21-2018 |
| 6 | Med Tec Inc | II | Jun-15-2016 |
| 7 | Siemens Medical Solutions USA, Inc | II | Jan-17-2014 |