IYY · Synchronizer, Electrocardiograph, Nuclear
Radiology · 21 CFR 892.1410 · Class 1
Overview
| Product Code | IYY |
|---|---|
| Device Name | Synchronizer, Electrocardiograph, Nuclear |
| Regulation | 21 CFR 892.1410 |
| Device Class | Class 1 |
| Review Panel | Radiology |
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.
Recent Cleared Devices (3 of 3)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K853737 | VEST(AMBULATORY VENTRICULAR EVALUATING SYSTEM) | Capintec, Inc. | Feb 13, 1986 | SESE |
| K790213 | GENERATOR, R-WAVE | Amr Co. | Mar 22, 1979 | SESE |
| K780510 | NUCLEAR STETHOSCOPE | Bios, Inc. | Apr 18, 1978 | SESE |
Top Applicants
- Amr Co. — 1 clearance
- Bios, Inc. — 1 clearance
- Capintec, Inc. — 1 clearance
