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e-CFR data is current as of January 15, 2021

Title 21Chapter ISubchapter HPart 892Subpart B → §892.1110


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


§892.1110   Positron camera.

(a) Identification. A positron camera is a device intended to image the distribution of positron-emitting radionuclides in the body. 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 48444, Nov. 20, 1990, as amended at 66 FR 46953, Sept. 10, 2001]

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