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EC9-4 Transducer

by Siemens Medical Solutions USA, Inc.

510(k) K060879

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 · Special NumberK060879 Date19 Apr 2006ClearedStatusActive

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  • Withdrawn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)

Full name
Model EC9-4 Transducer
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, 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 EC9-4 Transducer is a curved array endocavitary ultrasound probe, designed for internal imaging applications. It falls under the category of endocavitary transducers, which are used to visualize internal organs and structures via ultrasound technology, particularly in gynecological and obstetric assessments.

This device is supplied as a reusable component for ultrasound systems and is intended for use in clinical settings where internal imaging is required. It is not sterile upon delivery and must be cleaned and processed according to established infection control protocols. The EC9-4 Transducer holds an FDA 510(k) clearance under the product code ITX, with a decision classification of Substantially Equivalent, and is categorized under the Radiology advisory committee.

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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.

  • Is the EC9-4 Transducer meant for single-use or can it be reused in a clinical setting?

    The EC9-4 Transducer is designed as a reusable component for ultrasound systems. Since it is not sterile upon delivery, it must be cleaned and processed according to established infection control protocols before each use to ensure safety and compliance with clinical standards.

  • What types of internal imaging procedures is the EC9-4 Transducer primarily used for?

    The EC9-4 Transducer is a curved array endocavitary ultrasound probe, specifically intended for internal imaging applications in gynecological and obstetric assessments. This includes visualizing internal organs and structures within these specialties.

  • How is the EC9-4 Transducer supplied, and what preparation is required before clinical use?

    The EC9-4 Transducer is supplied as a reusable component and is not sterile upon delivery. Before clinical use, it must be thoroughly cleaned and processed following established infection control protocols to ensure it is safe for patient contact.

  • What regulatory pathway was followed for FDA clearance of the EC9-4 Transducer?

    The EC9-4 Transducer received FDA clearance through a 510(k) submission (K060879) under the ITX product code, with a decision classification of Substantially Equivalent (SESE). The review was conducted by the Radiology (RA) Advisory Committee under a Special clearance type.