← Product Code [JOP](/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/JOP) · K843620

# SCANHEADS-ACCESS 10PV, BIOSTATIC (K843620)

_Advanced Technology Laboratories, Inc. · JOP · Mar 12, 1985 · Cardiovascular · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/JOP/K843620

## Device Facts

- **Applicant:** Advanced Technology Laboratories, Inc.
- **Product Code:** [JOP](/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/JOP.md)
- **Decision Date:** Mar 12, 1985
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 870.2880
- **Device Class:** Class 2
- **Review Panel:** Cardiovascular

## Regulatory Identification

An ultrasonic transducer is a device applied to the skin to transmit and receive ultrasonic energy that is used in conjunction with an echocardiograph to provide imaging of cardiovascular structures. This device includes phased arrays and two-dimensional scanning transducers.

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**Source:** [https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/JOP/K843620](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/JOP/K843620)

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