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Echotech 3D FreeScan

by Echotech 3D Imaging Systems GmbH

510(k) K980308

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 NumberK980308 Date6 May 1998ClearedStatusActive

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  • Withdrawn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
IYO
Device Class
Class II
Regulation
21 CFR Part 892.1560
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 Echotech 3D FreeScan is a Class II ultrasound system that acquires related sets of 2D ultrasound images and performs 3D reconstruction of diagnostic ultrasound images. It is designed to acquire, analyze, store and retrieve digital ultrasound images for computerized 3-dimensional image processing. This system functions as an add-on accessory for existing ultrasound imaging systems.

The Echotech 3D FreeScan is supplied as a medical imaging system and is intended for use in radiology departments. It received FDA 510(k) clearance in 1998 under K-number K980308. The device is regulated as a Class II medical device and is designed to integrate with existing ultrasound imaging systems for enhanced diagnostic capabilities.

Other devices from Echotech 3D Imaging Systems GmbH

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 clinical purpose does the ECHOTECH 3D FreeScan serve?

    It is intended for radiology departments to acquire sets of 2D ultrasound images and generate three‑dimensional reconstructions, enhancing diagnostic evaluation of anatomical structures.

  • How is the FreeScan supplied and integrated with existing equipment?

    The system is provided as an add‑on accessory that connects to a compatible ultrasound imaging platform, allowing the existing hardware to perform 3D image processing without replacing the primary scanner.

  • Is the ECHOTECH 3D FreeScan a single‑use device or reusable?

    The FreeScan is a reusable medical imaging system; it is designed for repeated use in clinical settings and is not classified as a disposable or single‑use product.

  • What regulatory pathway was used for the FreeScan’s clearance?

    The device received FDA 510(k) clearance in 1998 under a traditional submission (K980308), indicating it was found substantially equivalent to a legally marketed predicate device.