FLEXIVIEW 8800 DIGITAL MOBILE IMAGING SYSTEM
Device Facts
| Record ID | K003837 |
|---|---|
| Device Name | FLEXIVIEW 8800 DIGITAL MOBILE IMAGING SYSTEM |
| Applicant | Ge Oec Medical Systems |
| Product Code | OXO · Radiology |
| Decision Date | Mar 12, 2001 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.1650 |
| Device Class | Class 2 |
Regulatory Classification
Identification
An image-intensified fluoroscopic x-ray system is a device intended to visualize anatomical structures by converting a pattern of x-radiation into a visible image through electronic amplification. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.
Special Controls
*Classification.* Class II (special controls). An anthrogram tray or radiology dental tray intended for use with an image-intensified fluoroscopic x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9. In addition, when intended as an accessory to the device described in paragraph (a) of this section, the fluoroscopic compression device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
