21 CFR 892.1610 — Aperture, Radiographic
Radiology (RA) · Subpart B—Diagnostic Devices · § 892.1610
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.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| IZS | Aperture, Radiographic | 2 | 1 | |
| IZT | Cone, Radiographic | 2 | 1 | |
| IZW | Collimator, Automatic, Radiographic | 2 | 23 | |
| IZX | Collimator, Manual, Radiographic | 2 | 17 | |
| KPW | Device, Beam Limiting, X-Ray, Diagnostic | 2 | 16 |
Special Controls
IZS — Aperture, Radiographic
*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.
eCFR
IZT — Cone, Radiographic
*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.
eCFR
IZW — Collimator, Automatic, Radiographic
*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.
eCFR
IZX — Collimator, Manual, Radiographic
*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.
eCFR
KPW — Device, Beam Limiting, X-Ray, Diagnostic
*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.
eCFR
