# K190995: ExactVu High Resolution Micro-Ultrasound System

- Pathway: 510(k) (Special)
- Applicant: Exact Imaging, Inc.
- Decided: May 10, 2019 after 24 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: 6 generations back to K000567 (2000). 8 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K180636: ExactVu High Resolution Micro-Ultrasound System, Exact Imaging, Inc. (2018) Summary page 4.

## Most influential descendants
- K192303: ExactVu High Resolution Micro-Ultrasound System (2019), 0 descendants of its own

## Indications for use
The ExactVu micro-ultrasound system is intended for use by qualified medical professionals for diagnostic ultrasound imaging or fluid flow analysis of the human body. The indications for use (clinical applications) are: • Small Organ • Transrectal • Abdominal The system may be used with patients of all ages, but is not designed for pediatric or fetal use. The system is contraindicated for direct cardiac application and for ophthalmic use or any application that causes the acoustic beam to pass through the eye.

Source page: https://510kreport.com/device/K190995
Methodology: https://510kreport.com/methodology