Browse hierarchy: [Radiology (RA)](/submissions/RA) → [Subpart B — Diagnostic Devices](/submissions/RA/subpart-b%E2%80%94diagnostic-devices) → [21 CFR 892.1970](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/892.1970) → IXO — Synchronizer, Ecg / Respirator, Radiographic

# IXO · Synchronizer, Ecg / Respirator, Radiographic

_Radiology · 21 CFR 892.1970 · Class 1_

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

## Overview

- **Product Code:** IXO
- **Device Name:** Synchronizer, Ecg / Respirator, Radiographic
- **Regulation:** [21 CFR 892.1970](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/892.1970)
- **Device Class:** 1
- **Review Panel:** [Radiology](/submissions/RA)

## Identification

A radiographic ECG/respirator synchronizer is a device intended to be used to coordinate an x-ray film exposure with the signal from an electrocardiograph (ECG) or respirator at a predetermined phase of the cardiac or respiratory cycle.

## 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 (4 of 4)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K854976](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IXO/K854976.md) | RMI RESPIRATORY GATING SYSTEM MODEL 301 | Radiation Measurements, Inc. | May 7, 1986 | SESE |
| [K811587](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IXO/K811587.md) | SIEMENS ANGIOTRON | Siemens Corp. | Jul 10, 1981 | SESE |
| [K810588](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IXO/K810588.md) | SYNCHRONIZER #208 | Brattle Instrument Corp. | Apr 10, 1981 | SESE |
| [K791959](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IXO/K791959.md) | POST EXTRA SYSTOLIC POSTENTLATOR | Medrad, Inc. | Jan 9, 1980 | SESE |

## Top Applicants

- Siemens Corp. — 1 clearance
- Radiation Measurements, Inc. — 1 clearance
- Medrad, Inc. — 1 clearance
- Brattle Instrument Corp. — 1 clearance

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

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