| Device Type ID | 5353 |
| Device Name | System, X-ray, Fluoroscopic, Non-image-intensified |
| Regulation Description | Non-image-intensified Fluoroscopic X-ray 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 | 892.1660 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | JAB |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Expansion Pilot Program |