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Arietta 70/Arietta S70/Arietta V70 Diagnostic Ultrasound Scanner

by Hitachi Aloka Medical, Ltd. (Hitachi Aloka Medical

510(k) K134016

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

2 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 NumberK134016 Date28 Mar 2014ClearedStatusActive

Recalls

2 recalls · FDA

    • Terminated Z-1341-2020 FDA Class II initiated 31 Jan 2020 on shared 510(k) K134016

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

    • Terminated Z-2090-2017 FDA Class II initiated 2 May 2017

    The strength of the arm mounting mechanism was insufficient and had to be redesigned.

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  • Withdrawn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
FDA applicant
Hitachi Aloka Medical,Ltd. (Hitachi Aloka Medical
Device Class
Class II
Regulation
21 CFR Part 892.1550
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

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