Browse hierarchy: [Radiology (RA)](/submissions/RA) → [Subpart B — Diagnostic Devices](/submissions/RA/subpart-b%E2%80%94diagnostic-devices) → [21 CFR 892.1410](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/892.1410) → IYY — Synchronizer, Electrocardiograph, Nuclear

# IYY · Synchronizer, Electrocardiograph, Nuclear

_Radiology · 21 CFR 892.1410 · Class 1_

**Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IYY

## Overview

- **Product Code:** IYY
- **Device Name:** Synchronizer, Electrocardiograph, Nuclear
- **Regulation:** [21 CFR 892.1410](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/892.1410)
- **Device Class:** 1
- **Review Panel:** [Radiology](/submissions/RA)

## 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](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IYY/K853737.md) | VEST(AMBULATORY VENTRICULAR EVALUATING SYSTEM) | Capintec, Inc. | Feb 13, 1986 | SESE |
| [K790213](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IYY/K790213.md) | GENERATOR, R-WAVE | Amr Co. | Mar 22, 1979 | SESE |
| [K780510](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IYY/K780510.md) | NUCLEAR STETHOSCOPE | Bios, Inc. | Apr 18, 1978 | SESE |

## Top Applicants

- Capintec, Inc. — 1 clearance
- Bios, Inc. — 1 clearance
- Amr Co. — 1 clearance

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**Source:** [https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IYY](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IYY)

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