X-ray Field Indicator Light (laser)
Device Code: 5430
Product Code(s):
RGC Definition: A Laser Incorporated In A Diagnostic X-ray System That Is Irradiated Onto The Film Screen Area Indicating The X-radiation Area. The Beam Is Usually Scanned To Show A Rectangular Region For Patient Placement.
Device Classification Information
| Device Type ID | 5430 |
| Device Name | X-ray Field Indicator Light (laser) |
| Physical State | Laser Light |
| Technical Method | A Laser Incorporated In A Diagnostic X-ray System That Is Irradiated Onto The Film Screen Area Indicating The X-radiation Area. The Beam Is Usually Scanned To Show A Rectangular Region For Patient Placement. |
| Target Area | Body |
| Regulation Description | Light Beam Patient Position Indicator. |
| Regulation Medical Specialty | Radiology |
| Review Panel | Radiology |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR)
|
| Submission Type | 510(K) Exempt |
| CFR Regulation Number | 892.5780 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | RGC |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
Recognized Standards
Total Product Life Cycle
| Device Type ID | 5430 |
| Device | X-ray Field Indicator Light (laser) |
| Product Code | RGC |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Light Beam Patient Position Indicator. |
| CFR Regulation Number | 892.5780 [🔎] |
TPLC Last Update: 2019-04-02 21:06:08