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Scanflex Solid Couplant Membrane

by Sonotech, Inc.

510(k) K983691

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 NumberK983691 Date5 May 1999ClearedStatusActive

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  • Withdrawn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.

The Scanflex Solid Couplant Membrane is an acoustic coupling medium designed for use in diagnostic ultrasound procedures. It functions as a replacement for traditional liquid or gel couplants and serves as a substitute for protective transducer covers made of latex, polyurethane, or polypropylene.

This device is intended for use in both sterile and non-sterile clinical environments. It has received FDA 510(k) clearance under the product code ITX.

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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 primary function of the Scanflex Solid Couplant Membrane?

    This device acts as an acoustic coupling medium for diagnostic ultrasound procedures. It is designed to replace traditional liquid or gel couplants while simultaneously serving as a substitute for protective transducer covers made of latex, polyurethane, or polypropylene.

  • In what clinical settings can this membrane be used?

    The Scanflex Solid Couplant Membrane is intended for use in both sterile and non-sterile clinical environments, providing flexibility for various diagnostic ultrasound applications.

  • What is the regulatory status of the Scanflex Solid Couplant Membrane?

    The device has received FDA 510(k) clearance under the product code ITX, which indicates that it has been determined to be substantially equivalent to legally marketed predicate devices.