IZT · Cone, Radiographic
Radiology · 21 CFR 892.1610 · Class 2
Overview
| Product Code | IZT |
|---|---|
| Device Name | Cone, 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 |
|---|---|---|---|---|
| K924759 | COLLIMATOR LIGHT SOURCE | Denar Corp. | Dec 9, 1992 | SESE |
Top Applicants
- Denar Corp. — 1 clearance
