Title 21: Food and Drugs
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/ PART 892 - RADIOLOGY DEVICES
/ Subpart B - Diagnostic Devices / § 892.1410 Nuclear electrocardiograph synchronizer.
§ 892.1410 Nuclear electrocardiograph synchronizer.
(a) Identification. A nuclear electrocardiograph synchronizer is a device intended for use in nuclear radiology to relate the time of image formation to the cardiac cycle during the production of dynamic cardiac images.
(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 § 892.9.