21 CFR 892.1320 — Probe, Uptake, Nuclear
Radiology (RA) · Subpart B—Diagnostic Devices · § 892.1320
Identification
A nuclear uptake probe is a device intended to measure the amount of radionuclide taken up by a particular organ or body region. This generic type of device may include a single or multiple detector probe, signal analysis and display equipment, patient and equipment supports, component parts, and accessories.
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 |
|---|---|---|---|---|
| IZD | Probe, Uptake, Nuclear | 1 | 30 |
