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Title 21 Part 892 → Subpart B → §892.1320

Title 21 → Chapter I → Subchapter H → Part 892 → Subpart B → §892.1320

Electronic Code of Federal Regulations e-CFR

Title 21 Part 892 → Subpart B → §892.1320

e-CFR data is current as of October 17, 2019

Title 21Chapter ISubchapter HPart 892Subpart B → §892.1320


Title 21: Food and Drugs
PART 892—RADIOLOGY DEVICES
Subpart B—Diagnostic Devices


§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.

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


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