# K220295: Arietta 50

- Pathway: 510(k) (Abbreviated)
- Applicant: Fujifilm Healthcare Corporation
- Decided: Apr 29, 2022 after 86 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: 18 generations back to K935595 (1995). 84 ancestors in all.
No later device cites it as a predicate yet.
0 of 85 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K190248: Arietta 50, Hitachi Healthcare Americas (2019) Summary page 4.

## Indications for use
This ARIETTA 50 is intended for use by trained personnel (doctor, sonographer, etc.) while in a healthcare facility for the diagnostic ultrasound evaluation of Fetal, Abdominal, Intra-operative (Spec.), Pediatric, Small Organ (Spec.), A Small Organ (Spec.), Adult Cephalic, Trans-rectal, Trans-vaginal, Trans-esoph. (non-Card.), Musculo-skel. (Convent.), Musculo-skel. (Superfic.), Other (Wound), Cardiac Adult, Cardiac Pediatric, Transesophageal (card.), Peripheral vessel, Other (Gynecological), 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).

Source page: https://510kreport.com/device/K220295
Methodology: https://510kreport.com/methodology