# K102901: HI Vision Avius Diagnostic Ultrasound Scanner

- Pathway: 510(k) (Special)
- Applicant: Hitachi Medical Systems America, Inc.
- Decided: Oct 27, 2010 after 27 days
- Product code: IYN (System, Imaging, Pulsed Doppler, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1550
- Recalls of this device: 1 (0 Class I)
- 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.
60 later devices descend from it; 1 cites it directly.
0 of 128 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). Our OCR of the scanned summary read K093446, FDA’s number for Vita VMK Master (Vita Zahnfabrik H. Rauter GmbH & Co. Kg.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “HITACHI HI VISION Preirus Diagnostic Ultrasound Scanner”. Summary page 3.

## Most influential descendants
- K130308: Noblus Ultrasound Diagnostic System (2013), 59 descendants of its own
- 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

## Recalls of this device
- Apr 18, 2011 · Not classified · Z-2467-2011: Software anomaly. The Doppler Trace Measurement feature on certain models of the firm's diagnostic ultrasound systems, may, under certain conditions whereby multiple measurements are done sequentially

## Indications for use
The HI VISION Avius is intended for use by trained personnel (doctor, songrapher, 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 Avius are Bmode, Mmode, PW mode (Pulsed Wave Doppler), CW mode (Continuous Wave Doppler), Color Doppler, Amplitude Doppler (Color Plow Angiography), TDI (Tissue Doppler Imaging), 3D Imaging, 40 Imaging, and Real Time Tissue Elastography.

Source page: https://510kreport.com/device/K102901
Methodology: https://510kreport.com/methodology