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Ultrasound Imagaing System and Doppler Flowmeter

by Interspec, Inc.

510(k) K920678

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 NumberK920678 Date2 Apr 1992ClearedStatusActive

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  • Withdrawn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
ITX
Device Class
Class II
Regulation
21 CFR Part 892.1570
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 27 Sep 2026

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

An ultrasound imaging system and Doppler flowmeter is a diagnostic transducer device used for ultrasonic imaging and blood flow measurement. It is classified under product code ITX as a Class II device requiring special controls.

The device was cleared via the FDA 510(k) pathway under K920678, with a substantially equivalent determination made on April 2, 1992. It is manufactured by Interspec, Inc. in Ambler, Pennsylvania, and is intended for use in radiology settings as indicated by the advisory committee review.

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Questions

AI-generated answers, 27 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 is the Ultrasound Imaging System and Doppler Flowmeter used for?

    It is a diagnostic transducer device used for ultrasonic imaging and blood flow measurement, intended for use in radiology settings as indicated by the advisory committee review.

  • How was the Ultrasound Imaging System and Doppler Flowmeter cleared for market?

    The device was cleared via the FDA 510(k) pathway under K920678, with a substantially equivalent determination made on April 2, 1992, based on its comparison to a legally marketed predicate device.

  • Who manufactures the Ultrasound Imaging System and Doppler Flowmeter and where is it made?

    The device is manufactured by Interspec, Inc. in Ambler, Pennsylvania, United States, as specified in the authorization details.