IZS · Aperture, Radiographic
Radiology · 21 CFR 892.1610 · Class 2
Overview
| Product Code | IZS |
|---|---|
| Device Name | Aperture, Radiographic |
| Regulation | 21 CFR 892.1610 |
| Device Class | Class 2 |
| Review Panel | Radiology |
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.
Classification Rationale
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.
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.
Recent Cleared Devices (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K895084 | APERTURE | Custom Medical Products, Ltd. | Oct 27, 1989 | SESE |
Top Applicants
- Custom Medical Products, Ltd. — 1 clearance
