R 302
Device Facts
| Record ID | K946320 |
|---|---|
| Device Name | R 302 |
| Applicant | Ralco S.R.L. |
| Product Code | KPW · Radiology |
| Decision Date | May 11, 1995 |
| 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.
