SSA-340A (MODIFICATION)

K960602 · Toshiba America Medical Systems, In.C · IYN · Mar 21, 1996 · Radiology

Device Facts

• Record ID: K960602
• Device Name: SSA-340A (MODIFICATION)
• Applicant: Toshiba America Medical Systems, In.C
• Product Code: IYN · Radiology
• Decision Date: Mar 21, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1550
• Device Class: Class 2

Intended Use

Color Angio is a post-processing modification to the Power Mode display that was cleared with the SSA-340A system in K941352. It is an amplitude based color display subset of color doppler imaging that performs frame addition to accentuate minute vascular structures and signal the presence of blood, rather than the motion of flow. This feature is independent of velocity, angle of incidence and direction of interrogation and reduces the effects of aliasing. It does not change the acoustic output or doppler sensitivity characteristics of the SSA-340A system.

Device Story

Color Angio is a software-based post-processing modification for the Toshiba SSA-340A diagnostic ultrasound system; functions as an amplitude-based color display subset of color Doppler imaging. Input: ultrasound echo signals. Processing: performs frame addition to accentuate minute vascular structures; signals presence of blood rather than motion of flow. Output: visual display of vascular structures. Operation: independent of velocity, angle of incidence, and direction of interrogation; reduces aliasing effects. Used in clinical settings by sonographers or physicians. Benefit: improved visualization of small vessels without changing acoustic output or Doppler sensitivity.

Clinical Evidence

Bench testing only. No clinical data provided. Compliance with CDRH guidance for diagnostic ultrasound, acoustic output reporting, and thermal/mechanical indices confirmed.

Technological Characteristics

Post-processing software modification for ultrasound imaging. Amplitude-based color display. Performs frame addition. Complies with IEC-601-1, ISO-9001, and 21 CFR 1010. No change to acoustic output or Doppler sensitivity.

Indications for Use

Indicated for diagnostic ultrasound imaging to accentuate minute vascular structures and signal the presence of blood flow in patients undergoing ultrasound examinations.

Regulatory Classification

Identification

An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

Predicate Devices

• SSA-340A Diagnostic Ultrasound System (K941352)

Submission Summary (Full Text)

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2460602

MAR 21 1996

K960602

510(k) Summary

Date: 26 February 1996

Submitter: Toshiba America Medical Systems, Inc.
2441 Michelle Drive
P.O. Box 2068
Tustin, CA 92681-2068

Contact: Steven M. Kay
[phone]

Classification Name: Ultrasonic Pulsed Echo Imaging System Modification

Classification: Class II per 21 CFR 892.1560

Device Tier: 2, according to the December 15, 1993 DRAERD Triage Pilot Program

Common Name: Amplitude Doppler

Proprietary Name: Color Angio

Model Name: Color Angio for the SSA-340A Diagnostic Ultrasound System

Establishment Registration Number: 2020563

## Compliance With Performance Standards:

This device complies with the Performance Standards for Electronic Products, 21 CFR 1010, as administered by the Center for Devices and Radiological Health and with CDRH guidances "Revised 510(k) Diagnostic Ultrasound Guidance for 1993", "510(k) Guide for Measuring and Reporting Acoustic Output of Diagnostic Ultrasound Medical Devices" and "Real Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment". It also complies with the Japanese (JIS) and European (IEC-601-1) voluntary standards and the ISO-9001 manufacturing standard.

## Substantial Equivalence Summary:

Color Angio is a post-processing modification to the Power Mode display that was cleared with the SSA-340A system in K941352. It is an amplitude based color display subset of color doppler imaging that performs frame addition to accentuate minute vascular structures and signal the presence of blood, rather than the motion of flow. This feature is independent of velocity, angle of incidence and direction of interrogation and reduces the effects of aliasing. It does not change the acoustic output or doppler sensitivity characteristics of the SSA-340A system.