# K153421: HI Vision Ascendus, HV Ascendus, Ascendus

- Pathway: 510(k) (Traditional)
- Applicant: Hitachi Aloka Medical America, Inc.
- Decided: Jan 21, 2016 after 57 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: 16 generations back to K935595 (1995). 94 ancestors in all.
No later device cites it as a predicate yet.
0 of 95 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 4.
- K142368: Noblus Diagnostic Ultrasound Scanner, Hitachi Aloka Medical, Ltd. (2015) Summary page 47.
- K130881: Acuson S2000 and S3000, Siemens Medical Solutions USA, Inc. (2013) Summary page 47.

## Indications for use
HI VISION Ascendus is intended for use by trained personnel (doctor, sonographer, etc.) for the diagnostic ultrasound evaluation of Abdominal, Cardiac, Intra-operative, Trans-esophageal (Cardiac, Non-Cardiac) - Adult/Pediatric, Fetal, Pediatric, Small Organ, Peripheral vessel, Biopsy, Trans-rectal, Trans-vaginal, Musculoskeletal (Convent. / Superfic.), Neonatal Cephalic, Adult Cephalic, Endoscopy, Intra-luminal, Gynecology, Urology and Laparoscopic clinical applications. The modes of operation of the HI VISION Ascendus are B mode, M mode, PW mode (Pulsed Wave Doppler), CW mode (Continuous Wave Doppler), Dual Doppler mode, CFI mode (Color Flow Image), Amplitude Dopper (Color Flow Angiography), TDI (Tissue Doppler Imaging), 3D Imaging, 4D Imaging, Real-time Virtual Sonography, Real-time Tissue Elastography and Shear Wave Measurement.

Source page: https://510kreport.com/device/K153421
Methodology: https://510kreport.com/methodology