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Noblus Diagnostic Ultrasound Scanner

by Hitachi Aloka Medical, Ltd.

510(k) K142368

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

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 NumberK142368 Date14 Jan 2015ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-1341-2020 FDA Class II initiated 31 Jan 2020 on shared 510(k) K142368

    These 18 probes may have mis-wiring in the inner cables, causing decreased sensitivity and thus resulting in lower peak velocity readings.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

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  • Withdrawn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, 24 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 Noblus Diagnostic Ultrasound Scanner is a Class II ultrasound system designed for diagnostic imaging. It utilizes fully digital circuits to support multiple clinical applications and features imaging technologies including HI Definition Tissue imaging, HI Compound Imaging, and Adaptive Imaging.

This portable system includes a removable console with an internal battery and wireless LAN connectivity. It is cleared under FDA 510(k) number K142368.

Other devices from Hitachi Aloka Medical, Ltd.

Questions

AI-generated answers, 24 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 imaging technologies are included in the Noblus system?

    The system utilizes fully digital circuits to support various clinical applications. It incorporates specific imaging technologies, including HI Definition Tissue imaging, HI Compound Imaging, and Adaptive Imaging to assist in diagnostic procedures.

  • Is the Noblus Diagnostic Ultrasound Scanner portable?

    Yes, the system is designed for portability. It features a removable console and includes an internal battery, allowing for flexibility in clinical environments where mobility is required.

  • Does the system support wireless connectivity?

    Yes, the Noblus Diagnostic Ultrasound Scanner is equipped with wireless LAN connectivity, which facilitates data management and integration within a clinical setting.

  • What is the regulatory status of this ultrasound scanner?

    The Noblus Diagnostic Ultrasound Scanner is cleared under FDA 510(k) number K142368. The device was determined to be substantially equivalent to predicate devices through a traditional submission process reviewed by the Radiology advisory committee.