C-arm Fluoroscopic X-ray System
Device Code: 5429
Product Code(s):
RCC Definition: Fluoroscopic X-ray System In Which The Image Receptor And X-ray Tube Housing Assembly Are Connected Or Coordinated To Maintain A Spatial Relationship. Such A System Allows A Change In The Direction Of The Beam Axis With Respect To The Patient Without
Device Classification Information
| Device Type ID | 5429 |
| Device Name | C-arm Fluoroscopic X-ray System |
| Regulation Description | 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 | 892.1650 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | RCC |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Program |
Recognized Standards
Total Product Life Cycle
| Device Type ID | 5429 |
| Device | C-arm Fluoroscopic X-ray System |
| Product Code | RCC |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Image-intensified Fluoroscopic X-ray System. |
| CFR Regulation Number | 892.1650 [🔎] |
| Device Problems |
|---|
Device Operational Issue | 1 |
| Total Device Problems | 1 |
TPLC Last Update: 2019-04-02 21:06:07