UST-5550-R; UST-5536-R; L43K— 510(k) K152126

Clearance details

Applicant

Hitachi Aloka Medical America, Inc.

Product code

Code ITX

Device class

Class 2

Regulation

21 CFR 892.1570

Advisory panel

Radiology

Date received

2015-07-31

Decision date

2016-08-17

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Wallingford, CT, US

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• K153421 — HI VISION ASCENDUS, HV ASCENDUS, ASCENDUS2016-01-21
• K142618 — Intra-operative Ultrasound Transducer, PROSOUND ALPHA 7 Diagnostic Ultrasound System, ARIETTA 70 Diagnostic Ultrasound System2014-10-16

Death

6

Injury

137

Malfunction

2,036

Total

2,179

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• Z-0816-2018 — Ultrasound Transducer, Model Number: UST-5550-R, is used in conjunction with a diagnostic ultrasound system evaluation during robotic and non-robotic intra-operative and laparoscopic procedures.Class II·Terminated·Hitachi Medical Systems America Inc·20171020

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K152126.