# K163505: Arietta Precision

- Pathway: 510(k) (Traditional)
- Applicant: Hitachi, Ltd.
- Decided: May 30, 2017 after 167 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: 14 generations back to K935595 (1995). 80 ancestors in all.
No later device cites it as a predicate yet.
0 of 81 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K134016: Arietta 70/Arietta S70/Arietta V70 Diagnostic Ultrasound Scanner, Hitachi Aloka Medical,Ltd. (Hitachi Aloka Medical (2014) Summary page 4.

## Indications for use
ARIETTA Precision is intended for use by trained personnel (doctor, sonographer, etc.) for the diagnostic ultrasound evaluation of Fetal, Abdominal (Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures (including amniocentesis.), Intra-operative (Includes imaging of organs and structures exposed during surgery (excluding neurosurgery and laparoscopic procedures.), Intra-operative (Neuro.), Laparoscopic, Pediatric, Small Organ (Includes thyroid, parathyroid, breast, scrotum, penis and imaging for guidance of biopsy.), Neonatal Cephalic, Adult Cephalic, Trans-rectal (Includes imaging for guidance of trans-rectal biopsy.), Trans-vaginal (Includes imaging for guidance of trans-vaginal biopsy.), Trans-esophageal (non-Cardiac - Adult/Pediatric), Musculo-skel. (Convent), Musculo-skel. (Superfic.), Other (spec.) -Wound (Includes imaging for Cavernous/Non-Cavernous wounds.), Other (spec) - Gynecological, Cardiac Adult, Cardiac Pediatric, Trans-esophageal (Cardiac - Adult/Pediatric) and 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) and TDI (Tissue Doppler Imaging), Trapezoid mode, Free Angular M mode.

Source page: https://510kreport.com/device/K163505
Methodology: https://510kreport.com/methodology