← Product Code [DXK](/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DXK) · K851901

# 750 SD ULTRASOUND SCANNER(MODIFICATION) (K851901)

_Ultrasonix, Inc. · DXK · Oct 23, 1985 · Cardiovascular · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DXK/K851901

## Device Facts

- **Applicant:** Ultrasonix, Inc.
- **Product Code:** [DXK](/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DXK.md)
- **Decision Date:** Oct 23, 1985
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 870.2330
- **Device Class:** Class 2
- **Review Panel:** Cardiovascular

## Regulatory Identification

An echocardiograph is a device that uses ultrasonic energy to create images of cardiovascular structures. It includes phased arrays and two-dimensional scanners.

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**Source:** [https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DXK/K851901](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DXK/K851901)

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