# K152126: Ust-5550-R; Ust-5536-R; L43K

- Pathway: 510(k) (Traditional)
- Applicant: Hitachi Aloka Medical America, Inc.
- Decided: Aug 17, 2016 after 383 days
- Product code: ITX (Transducer, Ultrasonic, Diagnostic)
- Device class: 2
- Regulation: 21 CFR 892.1570
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 16 generations back to K935595 (1995). 98 ancestors in all.
No later device cites it as a predicate yet.
0 of 99 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111227: Aloka SSD-3500 Diagnostic Ultrasound System, Aloka Co., Ltd. (2011) Summary page 7.
- K142368: Noblus Diagnostic Ultrasound Scanner, Hitachi Aloka Medical, Ltd. (2015) Summary page 6.

## Recalls of this device
- Oct 20, 2017 · Class II · Z-0816-2018: The ultrasound probe may not have adequate protection against electrical shock hazards.

## Indications for use
The UST-5550-R and UST-5536-R transducer is intended for use with the PROSOUND ALPHA 7 Diagnostic Ultrasound Systems by trained personnel (doctor, sonography, etc.) for the diagnostic ultrasound evaluation during robotic* and non-robotic** intra-operative and laparoscopic procedures. The L43K transducer is intended for use with the ARIETTA60, ARIETTA70 and NOBLUS Diagnostic Ultrasound Systems by trained personnel (doctor, sonography, etc.) for diagnostic ultrasound evaluation during robotic* and non-robotic** intra-operative and laparoscopic procedures. This device is not indicated for Ophthalmic applications. *For robotic use, these devices can only be used with the da Vinci™ Surgical System and da Vinci™ 8 mm ProGrasp Forceps. **For non-robotic use, these devices can only be used with the Covidien SILS™ Clinch

Source page: https://510kreport.com/device/K152126
Methodology: https://510kreport.com/methodology