← Product Code [ITX](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/ITX) · K802438

# MARK V DUPLEX ULTRASONIC SCAN SYS. (K802438)

_Advanced Technology Laboratories, Inc. · ITX · Jan 21, 1981 · Radiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/ITX/K802438

## Device Facts

- **Applicant:** Advanced Technology Laboratories, Inc.
- **Product Code:** [ITX](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/ITX.md)
- **Decision Date:** Jan 21, 1981
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 892.1570
- **Device Class:** Class 2
- **Review Panel:** Radiology

## Regulatory Identification

A diagnostic ultrasonic transducer is a device made of a piezoelectric material that converts electrical signals into acoustic signals and acoustic signals into electrical signals and intended for use in diagnostic ultrasonic medical devices. Accessories of this generic type of device may include transmission media for acoustically coupling the transducer to the body surface, such as acoustic gel, paste, or a flexible fluid container.

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**Source:** [https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/ITX/K802438](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/ITX/K802438)

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