CFR > Title 21 - Food and Drugs > CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES > SUBCHAPTER H—MEDICAL DEVICES (parts 800 to 898) > PART 892—RADIOLOGY DEVICES > SUBPART B—Diagnostic Devices (§892.1000 to §892.2050) > 892.1830—Radiologic patient cradle.

892.1830—Radiologic patient cradle.

(a) 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.
(b) Classification. 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.

Code of Federal Regulations

[53 FR 1567, Jan. 20, 1988, as amended at 61 FR 1125, Jan. 16, 1996; 66 FR 38819, July 25, 2001]