# K153620: Enovare Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: Oreon Technologies, Inc.
- Decided: May 5, 2016 after 139 days
- Product code: IYO (System, Imaging, Pulsed Echo, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1560
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K000567 (2000). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123254: Ultrasound Scanner Flex Focus, B-K Medical Aps (2013) Summary page 8.
- K043189: Sonalis, Model 2000, 3g Ultrasound, Inc. (2005) Summary page 8.

## Indications for use
The Enovare system’s ultrasound scanner connected with a probe enables real time diagnostic ultrasound imaging for B-mode, Tissue and Contrast Harmonic Imaging, PWD, Power Doppler, Color Doppler and combined mode imaging. Signal Analysis and display. Guidance of biopsy and therapy needles, geometrical measurements and calculation of parameters. The system offers optional probes each type optimized to image structure and orientation of tissues during specific clinical applications. These include general Abdominal, Intraoperative, Cardiac, Neurosurgery, Transrectal, Small organs, Urological, Transvaginal, Musculoskeletal.

Source page: https://510kreport.com/device/K153620
Methodology: https://510kreport.com/methodology