# K162583: Aloka Lisendo 880

- Pathway: 510(k) (Traditional)
- Applicant: Hitachi, Ltd.
- Decided: Nov 17, 2016 after 63 days
- Product code: IYN (System, Imaging, Pulsed Doppler, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1550
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 14 generations back to K935595 (1995). 80 ancestors in all.
No later device cites it as a predicate yet.
0 of 81 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K134016: Arietta 70/Arietta S70/Arietta V70 Diagnostic Ultrasound Scanner, Hitachi Aloka Medical,Ltd. (Hitachi Aloka Medical (2014) Summary page 4.

## Recalls of this device
- Oct 14, 2021 · Class II · Z-0191-2022: Diagnostic ultrasound system with the specified software version and used in conjunction with a Fujifilm (formally Hitachi) transducer does not display the measurement results correctly with two cardi
- Jan 31, 2020 · Class II · Z-1341-2020: These 18 probes may have mis-wiring in the inner cables, causing decreased sensitivity and thus resulting in lower peak velocity readings.

## Indications for use
ALOKA LISENDO 880 is intended for use by trained personnel (doctor, sonographer, etc.) for the diagnostic ultrasound evaluation of Fetal, Abdominal, Pediatric, Small Organ (Spec.), Intra-operative (Spec.), Neonatal Cephalic, Musculo-skel. (Convent./Superfic.), Peripheral vessel, Cardiac Adult, Cardiac Pediatric, Trans-esoph. (non-Card.), Trans-esophageal (card.), Adult Cephalic clinical applications. The Modes of Operation are B mode, M mode, PW mode (Pulsed Wave Doppler), CW mode (Continuous Wave Doppler), Color Doppler, Power Doppler, Amplitude Doppler (Color Flow Angiography), TDI (Tissue Doppler Imaging), 3D Imaging, 4D Imaging.

Source page: https://510kreport.com/device/K162583
Methodology: https://510kreport.com/methodology