SMS 90-15 R&F TABLE AND SMS 14 SPOT FILM DEVICE
Device Facts
| Record ID | K882019 |
|---|---|
| Device Name | SMS 90-15 R&F TABLE AND SMS 14 SPOT FILM DEVICE |
| Applicant | General Electric Co. |
| Product Code | IXR · Radiology |
| Decision Date | May 31, 1988 |
| 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.
