# K183456: Aloka Arietta 850

- Pathway: 510(k) (Traditional)
- Applicant: Hitachi Healthcare Americas
- Decided: Jan 28, 2019 after 46 days
- Product code: IYN (System, Imaging, Pulsed Doppler, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1550
- Recalls of this device: 3 (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.
2 later devices descend from it; 2 cite it directly.
0 of 85 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
- K231941: ARIETTA x10 (2023), 0 descendants of its own
- K191233: Arietta 750 (2019), 0 descendants of its own

## Recalls of this device
- Oct 14, 2021 · Class II · Z-0190-2022: 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
- Jun 30, 2021 · Class II · Z-2308-2021: The screw cover at the tip of the probe may fall off after a cleaning and sterilization process. Users advised to conduct a preventive inspection of the probe before and after sterilization/disinfecti
- Mar 1, 2021 · Class II · Z-1282-2021: Arietta 850 software version 4.0.0., 4.0.1, and 4.0.2 has an error in the focus point and transducer aperture settings in the SWE function. When the affected software with SWE function is used in conj

## Indications for use
The ALOKA ARIETTA 850 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, and gastro-intestinal (GI) endoscopic 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/K183456
Methodology: https://510kreport.com/methodology