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AU6 (Technos/Technos Mp) Ultrasound Imaging System (Addition of 3D Imaging Mode and Musculoskeletal Indication)

by Biosound Esaote, Inc.

510(k) K014168

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

Overview

The AU6 (TECHNOS/TECHNOS MP) ULTRASOUND IMAGING SYSTEM is a cutting-edge, FDA-cleared medical device that combines traditional radiology imaging with enhanced musculoskeletal indications. This advanced ultrasound system offers superior diagnostic clarity and accuracy, making it an ideal solution for various medical applications.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK014168 Date25 Apr 2002ClearedStatusActive

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  • Withdrawn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
IYN
Device Class
Class II
Regulation
21 CFR Part 892.1550
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

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