OMEGA III ANGIOGRAPHIC TABLE, ROTATION & STEPPER
Device Facts
| Record ID | K871827 |
|---|---|
| Device Name | OMEGA III ANGIOGRAPHIC TABLE, ROTATION & STEPPER |
| Applicant | General Electric Co. |
| Product Code | KXJ · Radiology |
| Decision Date | Jun 19, 1987 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.1980 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A radiologic table is a device intended for medical purposes to support a patient during radiologic procedures. The table may be fixed or tilting and may be electrically powered.
Special Controls
*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 892.9.
