OIO · Radiographic Contrast Tray
Radiology · 21 CFR 892.1680 · Class 2
Overview
| Product Code | OIO |
|---|---|
| Device Name | Radiographic Contrast Tray |
| Regulation | 21 CFR 892.1680 |
| Device Class | Class 2 |
| Review Panel | Radiology |
Identification
A stationary x-ray system is a permanently installed diagnostic system intended to generate and control x-rays for examination of various anatomical regions. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.
Classification Rationale
Class II (special controls). A radiographic contrast tray or radiology diagnostic kit intended for use with a stationary 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.
Special Controls
*Classification.* Class II (special controls). A radiographic contrast tray or radiology diagnostic kit intended for use with a stationary 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.
Recent Cleared Devices (0 of 0)
No cleared devices on record.
