eCFR Reference Browser

---

title: "21 CFR §892.1300"

source: "https://www.ecfr.gov/current/title-21/section-892.1300"

title_number: "21"

volume_number: "8"

chapter_number: "Unknown"

subchapter_code: "H"

subchapter_subject: "MEDICAL DEVICES"

part_code: "892"

part_subject: "RADIOLOGY DEVICES"

subpart_code: "B"

subpart_subject: "Diagnostic Devices"

section_number: "892.1300"

section_subject: "Nuclear rectilinear scanner."

cfr_reference: "21 CFR 892.1300"

title_name: "Title 21"

title_subject: "Food and Drugs"

parts_covered: "Parts 800 to 1299"

revised_date: "Revised as of April 1, 2019"

publication_date: "As of April 1, 2019"

contains_description: "Containing a codification of documents of general applicability and future effect"

publication_info: "Published by the Office of the Federal Register National Archives and Records Administration as a Special Edition of the Federal Register"

---

(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.

§892.1300 - Nuclear rectilinear scanner.