21 C.F.R. § 892.1320

Current through October 31, 2024
Section 892.1320 - Nuclear uptake probe
(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 .

21 C.F.R. §892.1320

55 FR 48444, Nov. 20, 1990, as amended at 65 FR 2322 , Jan. 14, 2000