← Product Code [ITX](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/ITX) · K010883

# TERATECH MODEL 8EC4 ENDOCAVITY SMART PROBE (K010883)

_Teratech Corp. · ITX · Apr 6, 2001 · Radiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/ITX/K010883

## Device Facts

- **Applicant:** Teratech Corp.
- **Product Code:** [ITX](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/ITX.md)
- **Decision Date:** Apr 6, 2001
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 892.1570
- **Device Class:** Class 2
- **Review Panel:** Radiology
- **Attributes:** 3rd-Party Reviewed

## 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/K010883](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/ITX/K010883)

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