21 C.F.R. § 892.1320 Nuclear uptake probe.
Title 21 - Food and Drugs
(a) 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. (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 §892.9. [55 FR 48444, Nov. 20, 1990, as amended at 65 FR 2322, Jan. 14, 2000]
Title 21: Food and Drugs
PART 892—RADIOLOGY DEVICES
Subpart B—Diagnostic Devices
§ 892.1320 Nuclear uptake probe.
