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Cardioscan Doppler Option

by Interspec, Inc.

510(k) K860579

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK860579 Date30 Jun 1986ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 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  • Withdrawn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
JOP
Device Class
Class II
Regulation
21 CFR Part 870.2880
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 Sep 2026

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

The Cardioscan Doppler Option is an ultrasonic transducer designed for cardiovascular imaging. It integrates Doppler functionality to assess blood flow dynamics, complementing echocardiographic evaluations for diagnostic purposes in cardiac assessments.

This device is supplied as a reusable component within a broader ultrasound system and is intended for use in clinical settings. It is classified as a Class 2 medical device under FDA regulations (product code JOP) and requires adherence to sterility and maintenance protocols as specified by the manufacturer. Authorized under FDA 510(k) clearance (K860579), it operates within the scope of cardiovascular diagnostics and is regulated under 21 CFR 870.2880.

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Questions

AI-generated answers, 19 Sep 2026

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

  • What types of blood flow assessments can the Cardioscan Doppler Option perform during echocardiographic evaluations?

    The Cardioscan Doppler Option is designed to integrate Doppler functionality specifically for assessing blood flow dynamics in cardiovascular imaging. This allows clinicians to evaluate parameters such as velocity, direction, and turbulence of blood flow within the heart and surrounding vessels, enhancing diagnostic accuracy during echocardiographic evaluations.

  • Is the Cardioscan Doppler Option intended for single-use or can it be reused in clinical settings?

    The Cardioscan Doppler Option is supplied as a reusable component within an ultrasound system. However, it requires adherence to strict sterility and maintenance protocols as outlined by the manufacturer to ensure safe and effective reuse in clinical environments.

  • What regulatory pathway was followed for the FDA clearance of the Cardioscan Doppler Option?

    The Cardioscan Doppler Option received FDA clearance through a traditional 510(k) submission (K860579), with a decision dated June 30, 1986. It was determined to be substantially equivalent to a predicate device and falls under the cardiovascular diagnostic category (product code JOP).

  • What types of ultrasound systems is the Cardioscan Doppler Option compatible with?

    The Cardioscan Doppler Option is designed as a reusable transducer component meant to integrate with broader ultrasound systems for cardiovascular imaging. While the exact compatibility depends on the manufacturer’s specifications, it is intended for use within systems that support Doppler functionality for echocardiographic assessments.