# K202422: Arietta 65

- Pathway: 510(k) (Traditional)
- Applicant: Hitachi Healthcare Americas
- Decided: Nov 4, 2020 after 72 days
- Product code: IYN (System, Imaging, Pulsed Doppler, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1550
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 17 generations back to K935595 (1995). 83 ancestors in all.
No later device cites it as a predicate yet.
0 of 84 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K181376: Arietta 65, Hitachi Healthcare Americas Corporation (2018) Summary page 4.

## Indications for use
This ARIETTA 65 is intended for use in a Healthcare facility (hospital, private medical office, etc.) by Healthcare trained personnel (doctor, sonographer, etc.) for the diagnostic ultrasound evaluation of Fetal, Abdominal, Intra-operative (Spec.), Intra-operative (Neuro.), Laparoscopic, Pediatric, Small Organ (Spec.), Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Trans-esoph. (non-Card.), Musculo-skel. (Convent.), Musculoskel. (Superfic.), Other (spec.) - Gynecological, Other (spec.) - Wound, 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/K202422
Methodology: https://510kreport.com/methodology