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Color Enhancement Function for the SSA-380A

by Toshiba America Medical Systems, In.C

510(k) K963705

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK963705 Date2 Dec 1996ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
IYN
Device Class
Class II
Regulation
21 CFR Part 892.1550
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Color Enhancement Function for the SSA-380A is an amplitude-based color display subset of color Doppler imaging. It performs frame addition to accentuate minute vascular structures and signal the presence of blood, rather than the motion of flow.

This device is a post-processing software modification for the SSA-380A ultrasound system. It is supplied as part of the ultrasound system and operates under the FDA 510(k) clearance K963705, which was granted on December 2, 1996, following a traditional review process.

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Questions

AI-generated answers, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Color Enhancement Function for the SSA-380A used for?

    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 detecting the motion of flow, enhancing visualization of small vessels in ultrasound exams.

  • How is the Color Enhancement Function for the SSA-380A supplied and integrated into the ultrasound system?

    It is supplied as a post-processing software modification that is part of the SSA-380A ultrasound system and operates under the FDA 510(k) clearance K963705, meaning it is not sold separately but functions as an integrated feature of the system.

  • Is the Color Enhancement Function for the SSA-380A a single-use or reusable component?

    As a software-based post-processing function, it is not a physical component subject to single-use or reuse limitations; it is reusable indefinitely as part of the ultrasound system's operating software, with no physical wear or degradation from use.