← Product Code [ITX](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/ITX) · K970034

# SD 800 SONODIAGNOST ULTRASOUND IMAGING SYSTEM (K970034)

_Hewlett-Packard Co. · ITX · Mar 17, 1997 · Radiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/ITX/K970034

## Device Facts

- **Applicant:** Hewlett-Packard Co.
- **Product Code:** [ITX](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/ITX.md)
- **Decision Date:** Mar 17, 1997
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 892.1570
- **Device Class:** Class 2
- **Review Panel:** Radiology

## Device Story

SD 800 SonoDiagnost Ultrasound Imaging System; diagnostic ultrasound imaging. Modification involves new patient contact materials for EV transducer. System utilizes existing transducer technology; acoustic performance maintained. Used in clinical settings for ultrasound imaging; provides diagnostic information to clinicians. Benefits include continued diagnostic capability with updated material components.

## Clinical Evidence

Bench testing only; acoustic performance evaluated per Appendix I of the February 1993 Ultrasound Guidance.

## Technological Characteristics

Ultrasound imaging system; EV transducer with updated patient contact materials. Acoustic performance consistent with predicate. No software or algorithm details provided.

## 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.

## Predicate Devices

- SD 800 and EV transducer ([K935923](/device/K935923.md))

## Submission Summary (Full Text)

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MAR 17 1997

Attachment C
SD 800 SW Modification K970034

510(k) Summary of Safety and Effectiveness: 21 CFR 807.92

1) Submitter's Name / Contact Person: Paul Schrader
Address: 3000 Minuteman Road, Andover Ma. 01810
Telephone Number: 508-659-2404
Date Summary was prepared: December 16, 1996

2) Trade Name: SD 800 SonoDiagnost Ultrasound Imaging System
Common Name: Ultrasound Imaging System
Classification Pro Codes: 90 IYN & 90 IYQ

3) Identification of Predicate Device:
The predicate device for this submittal is the existing SD 800 and EV transducer which were
reviewed by FDA on the SD 800 system that was submitted as part of K935923.

4) Description of the device or modification being submitted for premarket approval.

Functionality: The new EV transducer has equivalent functionality to the existing
transducer now being used.
Scientific Concepts: same as existing EV transducer
Significant Characteristics of the Modification: The new EV transducer has new patient
contact materials. It is this change that creates the need to file a 510(k) with the FDA.

The transducer is an existing transducer being sold and marketed by Echo ultrasound. Acoustic
performance of the system / transducer combination will be handled as a 510(k) to file based on
Appendix I of the February 1993 Ultrasound Guidance.

5) Statement of Intended Use: No change from existing SD 800 platform reviewed during
510(k) 935923.

6) Predicate Device Comparison: There are no significant differences in safety and efficacy
between the 21370A and 21370B transducers. A detailed comparison of the transducers can
be found in the 510(k) report.

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**Source:** [https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/ITX/K970034](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/ITX/K970034)

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