← Product Code [IYO](/productcode/IYO) · K963706

# PHILIPS SONO DIAGNOST 800 (K963706)

_Hewlett-Packard Co. · IYO · Mar 19, 1997 · Radiology · SESE_

**Canonical URL:** https://fda-staging.innolitics.com/device/K963706

## Device Facts

- **Applicant:** Hewlett-Packard Co.
- **Product Code:** [IYO](/productcode/IYO.md)
- **Decision Date:** Mar 19, 1997
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 892.1560
- **Device Class:** Class 2
- **Review Panel:** Radiology

## Device Story

SD 800 SonoDiagnost Ultrasound Imaging System modification; software update for automatic determination of flow angles in Doppler and CVI imaging. Input: ultrasound image data. Processing: algorithm calculates optimal flow angle. Output: automatic cursor placement on display. Usage: clinical ultrasound imaging; operated by sonographers. Benefit: reduced time for manual angle setting; manual override capability maintained for clinician control.

## Clinical Evidence

Bench testing only; no clinical data provided.

## Technological Characteristics

Ultrasound imaging system; software-based automatic flow angle calculation algorithm. Connectivity: integrated into SD 800 platform. Software: algorithm-based modification for automated cursor positioning.

## Regulatory Identification

An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

## Special Controls

*Classification.* Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.

## Predicate Devices

- SD 800 SonoDiagnost Ultrasound Imaging System ([K935923](/device/K935923.md))

## Submission Summary (Full Text)

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MAR 19 1997
K963706

# Attachment C
## SD 800 SW Modification

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: August 26, 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 existing SD 800 human interface controls 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: This SW modification allows for automatic determination of the flow angles used in Doppler and CVI imaging.
Scientific Concepts: The automatic flow angle is determined using an algorithm that is described in detail in Appendix C of the 510(k) report.

Significant Characteristics of the Modification: Since the flow angle will be set automatically use of this SW modification will reduce the time a sonographer needs to set the angle. The sonographer still has the ability to override the automatic placement if they do not like the automatic angle positioning.

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

6) Predicate Device Comparison: The SD 800 already has the ability to manually position the flow angle cursor in the image. The new SW allows this position to automatically be determined by the system. Both sets of SW allow for final manual adjustment of the position.

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**Source:** [https://fda-staging.innolitics.com/device/K963706](https://fda-staging.innolitics.com/device/K963706)

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