# K181376: Arietta 65

- Pathway: 510(k) (Traditional)
- Applicant: Hitachi Healthcare Americas Corporation
- Decided: Jul 18, 2018 after 55 days
- Product code: IYN (System, Imaging, Pulsed Doppler, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1550
- 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). 82 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 86 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K173739: Aloka Arietta 850, Hitachi Healthcare Americas Corporation (2018) Summary page 4.

## Most influential descendants
- K190248: Arietta 50 (2019), 1 descendant of its own
- K220295: Arietta 50 (2022), 0 descendants of its own
- K202422: Arietta 65 (2020), 0 descendants of its own

## Recalls of this device
- Oct 14, 2021 · Class II · Z-0192-2022: When the ultrasound system is used in combination with a Fujifilm (formally Hitachi) transducer, there is an error in the calculation formula of Effective Regurgitant Orifice Area (EROA) when you perf

## Indications for use
The ARIETTA 65 is intended for use by trained personnel (doctor, Sonographer, etc.) for the diagnostic ultrasound evaluation of Fetal, Abdominal, Intra-operative (Spec.), Pediatric, Small Organ (Spec.), Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Trans-esoph. (non-Card.), Musculo-skel. (Convent.), Musculo-skel. (Superfic.), Wound (Cavernous/Non-Cavernous), Gynecology, Cardiac Adult, Cardiac Pediatric, Trans-esophageal (card.), Peripheral vessel 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 (Color Flow Angiography), TDI (Tissue Doppler Imaging), 3D Imaging, 4D Imaging.

Source page: https://510kreport.com/device/K181376
Methodology: https://510kreport.com/methodology