21 CFR 892.1350 — Bed, Scanning, Nuclear
Radiology (RA) · Subpart B—Diagnostic Devices · § 892.1350
Identification
A nuclear scanning bed is an adjustable bed intended to support a patient during a nuclear medicine procedure.
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 § 892.9.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| IYZ | Bed, Scanning, Nuclear | 1 | 12 |