14X14 MULTIFORMAT SPOT FILMER, NO. 6650.400
Device Facts
| Record ID | K881589 |
|---|---|
| Device Name | 14X14 MULTIFORMAT SPOT FILMER, NO. 6650.400 |
| Applicant | Continental X-Ray Corp. |
| Product Code | IXL · Radiology |
| Decision Date | Jul 18, 1988 |
| 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.
