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e-CFR data is current as of November 25, 2020

Title 21Chapter ISubchapter HPart 892Subpart B → §892.1130


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


§892.1130   Nuclear whole body counter.

(a) Identification. A nuclear whole body counter is a device intended to measure the amount of radionuclides in the entire body. This generic type of device may include signal analysis and display equipment, patient and equipment supports, 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.

[53 FR 1567, Jan. 20, 1988, as amended at 59 FR 63015, Dec. 7, 1994; 66 FR 38818, July 25, 2001]

[55 FR 48444, Nov. 20, 1990]

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