# K093466: HI Vision Preirus Doagnostic Ultrasound Scanner Model HI Vision Preirus

- Pathway: 510(k) (Traditional)
- Applicant: Hitachi Medical Systems America, Inc.
- Decided: Jun 17, 2010 after 223 days
- Product code: IYO (System, Imaging, Pulsed Echo, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1560
- 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: 11 generations back to K935595 (1995). 66 ancestors in all.
96 later devices descend from it; 6 cite it directly.
0 of 163 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063518: HI Vision 900 Diagnostic Ultrasound Scanner, Hitachi Medical Systems America, Inc. (2006) Summary page 1.
- K082185: GE Logiq E9 Diagnostic Ultrasound System, Models 5205000, 5205000-2, Ge Medical Systems Ultrasound and Primary Care Dia (2008) Summary page 1.
- K072786: Acuson S2000 Ultrasound System, Siemens Medical Solutions USA, Inc. (2007) Summary page 1.

## Most influential descendants
- K110673: HI Vision Ascendus Diagnostic Ultrasound Scanner (2011), 85 descendants of its own
- K102901: HI Vision Avius Diagnostic Ultrasound Scanner (2010), 60 descendants of its own
- 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

## 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 Preirus isintended 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 Lapanoscopic clinical applications. The Modesof Operation of the HI VISION Preirus 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, 40 Imaging, Real Time Tissue Elastography, and Real Time Virtual Sonography.

Source page: https://510kreport.com/device/K093466
Methodology: https://510kreport.com/methodology