# K134016: Arietta 70/Arietta S70/Arietta V70 Diagnostic Ultrasound Scanner

- Pathway: 510(k) (Traditional)
- Applicant: Hitachi Aloka Medical,Ltd. (Hitachi Aloka Medical
- Decided: Mar 28, 2014 after 88 days
- Product code: IYN (System, Imaging, Pulsed Doppler, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1550
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 13 generations back to K935595 (1995). 79 ancestors in all.
25 later devices descend from it; 6 cite it directly.
0 of 105 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110673: HI Vision Ascendus Diagnostic Ultrasound Scanner, Hitachi Medical Systems America, Inc. (2011) Summary page 2.
- K123828: Prosound F75 Diagnostic Ultrasound System, Hitachi Aloka Medical, Ltd. (2013) Summary page 1.

## Most influential descendants
- K153277: 6200 Ultrasound System and 6250 Ultrasound System (2016), 12 descendants of its own
- K163082: 6200 Ultrasound System and 6250 Ultrasound System (2017), 9 descendants of its own
- K173291: 6440 Ultrasound System (2018), 8 descendants of its own
- K171708: Aloka Arietta 850 (2017), 8 descendants of its own
- K173739: Aloka Arietta 850 (2018), 7 descendants of its own

## Recalls of this device
- Jan 31, 2020 · Class II · Z-1341-2020: These 18 probes may have mis-wiring in the inner cables, causing decreased sensitivity and thus resulting in lower peak velocity readings.
- May 2, 2017 · Class II · Z-2090-2017: The strength of the arm mounting mechanism was insufficient and had to be redesigned.

## Indications for use
The Hitachi Aloka Medical, Ltd. Arietta70/ AriettaS70 /AriettaV70 is intended for use by trained personnel (doctor, sonographer, etc.) for the diagnostic ultrasound evaluation of Abdominal, Cardiac, Intra-operative, Fetal, Pediatric, Small Organ, Peripheral vessel, Biopsy, Trans-rectal, Trans-vaginal, Musculoskeletal, Neonatal Cephalic, Adult Cephalic, Endoscopy, Intra-luminal, Gynecology, Urology and Laparoscopic clinical applications. The Modes of Operation are B mode, M mode, PW mode (Pulsed Wave Doppler), CW mode (Continuous Wave Doppler), Color Doppler, Amplitude Doppler (Color Flow Angiography), TDI (Tissue Doppler Imaging), 3D Imaging, 4D Imaging, Real Time Tissue Elastography, and Real Time Virtual Sonography.

Source page: https://510kreport.com/device/K134016
Methodology: https://510kreport.com/methodology