21 CFR 892.1410 — Synchronizer, Electrocardiograph, Nuclear
Radiology (RA) · Subpart B—Diagnostic Devices · § 892.1410
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.
Classification Rationale
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.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| IYY | Synchronizer, Electrocardiograph, Nuclear | 1 | 3 |
