# K110673: HI Vision Ascendus Diagnostic Ultrasound Scanner

- Pathway: 510(k) (Traditional)
- Applicant: Hitachi Medical Systems America, Inc.
- Decided: Sep 27, 2011 after 202 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: 12 generations back to K935595 (1995). 67 ancestors in all.
85 later devices descend from it; 3 cite it directly.
0 of 153 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K093466: HI Vision Preirus Doagnostic Ultrasound Scanner Model HI Vision Preirus, Hitachi Medical Systems America, Inc. (2010) Summary page 1.

## Most influential descendants
- K142368: Noblus Diagnostic Ultrasound Scanner (2015), 58 descendants of its own
- K171048: RS80A Diagnostic Ultrasound System (2017), 50 descendants of its own
- K173204: RS85 Diagnostic Ultrasound System (2018), 39 descendants of its own
- K173513: WS80A Diagnostic Ultrasound System (2018), 32 descendants of its own
- K181336: HS50 / HS60 Diagnostic Ultrasound System (2018), 31 descendants of its own

## Indications for use
The HI VISION Ascendus 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 of the HI VISION Ascendus are Bmode, Mmode, 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/K110673
Methodology: https://510kreport.com/methodology