UST-5550-R; UST-5536-R; L43K

FDA 510(k) K152126 · Hitachi Aloka Medical America, Inc.

Substantially Equivalent

510(k) numberK152126

Submission

Device name
UST-5550-R; UST-5536-R; L43K
Applicant
Hitachi Aloka Medical America, Inc.
Wallingford, CT, US
Received
July 31, 2015
Decision date
August 17, 2016
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
ITX – Transducer, Ultrasonic, Diagnostic
Device class
Class II (moderate risk)
Regulation
21 CFR 892.1570
Specialty
Radiology

Other 510(k)s with product code ITX

510(k)DeviceApplicantDecision
K261170BA-004CCITX · Traditional Fujifilm Corporation08/12/2026SE
K254143EM-TECH Passive Ultrasound Probe StrapITX · Traditional EM-TECH Solutions, Inc.08/10/2026SE
K260161SmartGuide Disposable Guides and GridsITX · Traditional UC-CARE , Ltd.07/30/2026SE
K262474ND Needle Guidance SystemITX · Traditional Accurate Access, LLC07/27/2026SE
K261014Accuro® 3S Needle Guide KitITX · Traditional Rivanna Medical, Inc.07/24/2026SE
K250883Ultrasonic Probe UM-3R (UM-3R); Ultrasonic Probe UM-G20-29R (UM-G20-29R)ITX · Traditional Olympus Medical Systems Corporation09/18/2025SE
K250762Ultrasonic Probe UM-S20-17S (UM-S20-17S); Ultrasonic Probe UM-S20-20R (UM-S20-20R)ITX · Traditional Olympus Medical Systems Corporation07/11/2025SE
K250524Mendaera Guidance SystemITX · Traditional Mendaera, Inc.07/02/2025SE
K250469Accuro® 3S Needle Guide KitITX · Traditional Rivanna Medical, Inc.06/13/2025SE
K241662Ultrasound Transducer CoverITX · Traditional Vitrolife Sweden AB08/30/2024SE

More from Vitrolife Sweden AB

510(k)DeviceDecision
K153421Hi Vision Ascendus, HV Ascendus, AscendusIYN · Traditional 01/21/2016SE
K142618Intra-operative Ultrasound Transducer, PROSOUND ALPHA 7 Diagnostic Ultrasound System…ITX · Special 10/16/2014SE

Questions and answers

When was UST-5550-R; UST-5536-R; L43K cleared by the FDA?

UST-5550-R; UST-5536-R; L43K (K152126) received a 510(k) decision of Substantially Equivalent on August 17, 2016, 383 days after the submission was received.

What is the product code of K152126?

The FDA product code is ITX – Transducer, Ultrasonic, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 892.1570.