COLOR ENHANCEMENT FUNCTION FOR THE SSA-380A

K963705 · Toshiba America Medical Systems, In.C · IYN · Dec 2, 1996 · Radiology

Device Facts

• Record ID: K963705
• Device Name: COLOR ENHANCEMENT FUNCTION FOR THE SSA-380A
• Applicant: Toshiba America Medical Systems, In.C
• Product Code: IYN · Radiology
• Decision Date: Dec 2, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1550
• Device Class: Class 2

Intended Use

Color Enhancement Function for the SSA-380A 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.

Device Story

Color Enhancement Function (Color Angio) is a post-processing software modification for SSA-380A ultrasound system; utilizes amplitude-based color display; performs frame addition to accentuate minute vascular structures; signals presence of blood rather than motion; independent of velocity, angle of incidence, and direction of interrogation; reduces aliasing effects; operated by sonographers/physicians in clinical settings; output displayed on system monitor to assist in vascular visualization and clinical diagnosis.

Clinical Evidence

Bench testing only; no clinical data provided.

Technological Characteristics

Software-based post-processing modification for ultrasonic pulsed Doppler imaging system; amplitude-based signal processing; frame addition algorithm; independent of velocity/angle/direction; integrated into existing SSA-380A system architecture.

Indications for Use

Indicated for use as an accessory to the SSA-380A Ultrasonic Pulsed Doppler Imaging System to visualize blood flow and vascular structures in patients undergoing ultrasound examination.

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-380A system (K933743)

Submission Summary (Full Text)

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K963705

DEC - 3 1996

# 510(k) Summary

Submitter’s Name: Toshiba America Medical Systems, Inc.
Submitter’s Address: P.O. Box 2068, 2441 Michelle Drive, Tustin CA 92781-2068
Submitter’s Contact: Steven M. Kay, Regulatory Affairs Specialist, [phone]
Establishment Registration Number: 2020563

Device Proprietary Name: Color Enhancement Function for the SSA-380A
Common Name: Amplitude Doppler
Classification Name: Ultrasonic Pulsed Doppler Imaging System Accessory
[Fed. Reg. No.: 892.1550, Pro. Code: 90-IYN]
Device Track: Track 3

Regulatory Class: II ☑
514 Performance Standards: None
Special Controls: None
Prescription Status: Prescription Device

Reason for Submission:
Modification of the SSA-380A

## Substantial Equivalence Summary:

Color Angio is a post-processing modification to the Power Mode display that was cleared with the SSA-380A system in K933743. 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