Synchronizer, Electrocardiograph, Nuclear
A nuclear electrocardiograph synchronizer is used in nuclear cardiology to gate image acquisition to the cardiac cycle, allowing the scintillation camera to collect data correlated with specific phases of the heartbeat for improved cardiac imaging accuracy. It is classified as FDA Class 1, the lowest risk designation, subject only to general controls and not requiring premarket notification. The product code is IYY, regulated under 21 CFR 892.1410, within the Radiology medical specialty. No special flags apply to this device.
Research product code IYY in seconds
The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.
Free to try · every answer cites its records
Basic Information
- Product Code
- IYY
- Device Class
- FDA class 1
- Regulation Number
- 892.1410
- Medical Specialty
- Radiology
- Review Panel
- RA
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 3 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K853737 | VEST(AMBULATORY VENTRICULAR EVALUATING SYSTEM) | Feb 13, 1986 | Substantially Equivalent | Capintec, Inc. |
| K790213 | GENERATOR, R-WAVE | Mar 22, 1979 | Substantially Equivalent | Amr Co. |
| K780510 | NUCLEAR STETHOSCOPE | Apr 18, 1978 | Substantially Equivalent | Bios, Inc. |