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 CodeDevice NameClassDevicesAttributes
IYZBed, Scanning, Nuclear112
Innolitics

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