SFD-035 SPOT FILM DEVICE
Device Facts
| Record ID | K902146 |
|---|---|
| Device Name | SFD-035 SPOT FILM DEVICE |
| Applicant | Rms Div. |
| Product Code | IXL · Radiology |
| Decision Date | May 31, 1990 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.1670 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A spot-film device is an electromechanical component of a fluoroscopic x-ray system that is intended to be used for medical purposes to position a radiographic film cassette to obtain radiographs during fluoroscopy.
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 the limitations in § 892.9.
