21 CFR § 892.1100 - Scintillation (gamma) camera.

---
identifier: "/us/cfr/t21/s892.1100"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 892.1100 - Scintillation (gamma) camera."
title_number: 21
title_name: "Food and Drugs"
section_number: "892.1100"
section_name: "Scintillation (gamma) camera."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "H"
subchapter_name: "MEDICAL DEVICES"
part_number: "892"
part_name: "RADIOLOGY DEVICES"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 351, 360, 360c, 360e, 360j, 360 371."
regulatory_source: "53 FR 1567, Jan. 20, 1988, unless otherwise noted."
cfr_part: "892"
---


# 892.1100 Scintillation (gamma) camera.

(a) *Identification.* A scintillation (gamma) camera is a device intended to image the distribution of radionuclides in the body by means of a photon radiation detector. 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).

[55 FR 48443, Nov. 20, 1990, as amended at 66 FR 46953, Sept. 10, 2001]