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Title 21 Part 892 → Subpart B → §892.1380

Title 21 → Chapter I → Subchapter H → Part 892 → Subpart B → §892.1380

Electronic Code of Federal Regulations e-CFR

Title 21 Part 892 → Subpart B → §892.1380

e-CFR data is current as of December 12, 2019

Title 21Chapter ISubchapter HPart 892Subpart B → §892.1380


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


§892.1380   Nuclear flood source phantom.

(a) Identification. A nuclear flood source phantom is a device that consists of a radiolucent container filled with a uniformly distributed solution of a desired radionuclide. It is intended to calibrate a medical gamma camera-collimator system for uniformity of response.

(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.

[53 FR 1567, Jan. 20, 1988, as amended at 54 FR 13832, Apr. 5, 1989; 66 FR 38819, July 25, 2001]


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