21 CFR 892.1830 — Cradle, Patient, Radiologic
Radiology (RA) · Subpart B—Diagnostic Devices · § 892.1830
Identification
A radiologic patient cradle is a support device intended to be used for rotational positioning about the longitudinal axis of a patient during radiologic procedures.
Classification Rationale
Class I (general 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 |
|---|---|---|---|---|
| KXH | Cradle, Patient, Radiologic | 1 | 9 |
