UXM MODEL 8188
Device Facts
| Record ID | K840678 |
|---|---|
| Device Name | UXM MODEL 8188 |
| Applicant | Universal X-Ray |
| Product Code | IZX · Radiology |
| Decision Date | Mar 16, 1984 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.1610 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A diagnostic x-ray beam-limiting device is a device such as a collimator, a cone, or an aperture intended to restrict the dimensions of a diagnostic x-ray field by limiting the size of the primary x-ray beam.
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.
