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Title 21 Part 892 → Subpart B → §892.1370

Title 21 → Chapter I → Subchapter H → Part 892 → Subpart B → §892.1370

Electronic Code of Federal Regulations e-CFR

Title 21 Part 892 → Subpart B → §892.1370

e-CFR data is current as of July 18, 2019

Title 21Chapter ISubchapter HPart 892Subpart B → §892.1370


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


§892.1370   Nuclear anthropomorphic phantom.

(a) Identification. A nuclear anthropomorphic phantom is a human tissue facsimile that contains a radioactive source or a cavity in which a radioactive sample can be inserted. It is intended to calibrate nuclear uptake probes or other medical instruments.

(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 38818, July 25, 2001]