# K231941: ARIETTA x10

- Pathway: 510(k) (Traditional)
- Applicant: FUJIFILM Healthcare Americas Corporation
- Decided: Nov 20, 2023 after 143 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)
- K183456: Aloka Arietta 850, Hitachi Healthcare Americas (2019) Summary page 4.

## Indications for use
The ARIETTA x10 is intended for use by trained personnel (doctor, Sonographer, etc.) while in a healthcare facility for the diagnostic ultrasound evaluation of Fetal, Abdominal, lntraoperative (Specify*1 ), Intra-operative (Neurosurgery), Laparoscopic, Pediatric, Small Organ (Specify*2), Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Transesophageal (non-Cardiac), Musculo-skeletal (Conventional), Musculo-skeletal (Superficial), Other (Specify - Gynecological), Other (Specify- Wound), Cardiac Adult, Cardiac Pediatric, Trans-esophageal (Cardiac), 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), TOI (Tissue Doppler Imaging), 3D Imaging, 4D Imaging. *1. Includes imaging for organs and structures exposed during surgery (excluding neurosurgery and laparoscopic procedures). *2. Includes thyroid, parathyroid, breast, scrotum, penis.

Source page: https://510kreport.com/device/K231941
Methodology: https://510kreport.com/methodology