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7400 Ultrasound Systems

by Navigant Consulting - on Behalf of Esaote S.P.A.

510(k) K190447

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 NumberK190447 Date1 Apr 2019ClearedStatusActive

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  • Withdrawn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

Overview

AI-generated summary, 23 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 7400 Ultrasound Systems is an ultrasonic pulsed doppler imaging system designed for diagnostic general ultrasound studies. This compact portable system is intended for use in fetal, abdominal, intraoperative, laparoscopic, pediatric, small organ, and neonatal imaging applications.

This device is authorized under FDA 510(k) clearance K190447. It is classified as a Class II medical device under regulation 21 CFR 892.1550.

Questions

AI-generated answers, 23 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 clinical use of the 7400 Ultrasound Systems?

    This device is an ultrasonic pulsed doppler imaging system intended for diagnostic general ultrasound studies. It supports a wide range of applications including fetal, abdominal, intraoperative, laparoscopic, pediatric, small organ, and neonatal imaging.

  • Is the 7400 Ultrasound Systems designed for portability?

    Yes, the system is engineered as a compact, portable unit, allowing for flexibility in clinical settings where space may be limited or where the equipment needs to be moved between different patient care areas.

  • What is the regulatory status of this ultrasound system?

    The 7400 Ultrasound Systems is authorized under FDA 510(k) clearance K190447. It is classified as a Class II medical device under regulation 21 CFR 892.1550, which pertains to ultrasonic pulsed doppler imaging systems.