| Device Type ID | 5280 |
| Device Name | System, Radiation Therapy, Radionuclide |
| Regulation Description | Radionuclide 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 | 892.5750 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | IWB |
| 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 | 5280 |
| Device | System, Radiation Therapy, Radionuclide |
| Product Code | IWB |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Radionuclide Radiation Therapy System. |
| CFR Regulation Number | 892.5750 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
ELEKTA INSTRUMENT AB | ||
SUBSTANTIALLY EQUIVALENT | 6 | |
HYPER TECHNOLOGY INC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
XCISION MEDICAL SYSTEMS, LLC | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
| Device Problems | |
|---|---|
Computer Software Problem | 3 |
Misassembled | 3 |
Adverse Event Without Identified Device Or Use Problem | 1 |
Device Operates Differently Than Expected | 1 |
Positioning Problem | 1 |
Device Maintenance Issue | 1 |
Therapy Delivered To Incorrect Body Area | 1 |
Human Factors Issue | 1 |
| Total Device Problems | 12 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Elekta, Inc. | II | May-31-2017 |
| 2 | Elekta, Inc. | II | Apr-22-2016 |
| 3 | Elekta, Inc. | II | Jun-05-2015 |
| 4 | Elekta, Inc. | II | Oct-30-2014 |