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UST-5550-R - Ust-5536-R

by Hitachi Aloka Medical America, Inc.

510(k) K152126

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 NumberK152126 Date17 Aug 2016ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-0816-2018 FDA Class II initiated 20 Oct 2017

    The ultrasound probe may not have adequate protection against electrical shock hazards.

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  • Withdrawn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
ITX
Models / Variants
Ust-5536-R
Device Class
Class II
Regulation
21 CFR Part 892.1570
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

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