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Title 21 Part 892 → Subpart B → §892.1300

Title 21 → Chapter I → Subchapter H → Part 892 → Subpart B → §892.1300

Electronic Code of Federal Regulations e-CFR

Title 21 Part 892 → Subpart B → §892.1300

e-CFR data is current as of June 13, 2019

Title 21Chapter ISubchapter HPart 892Subpart B → §892.1300


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


§892.1300   Nuclear rectilinear scanner.

(a) Identification. A nuclear rectilinear scanner is a device intended to image the distribution of radionuclides in the body by means of a detector (or detectors) whose position moves in two directions with respect to the patient. This generic type of device may include signal analysis and display equipment, patient and equipment supports, radionuclide anatomical markers, 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 the limitations in §892.9.

[55 FR 48444, Nov. 20, 1990, as amended at 65 FR 2322, Jan. 14, 2000; 66 FR 38818, July 25, 2001]