# K192303: ExactVu High Resolution Micro-Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: Exact Imaging, Inc.
- Decided: Oct 1, 2019 after 39 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: 7 generations back to K000567 (2000). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K190995: ExactVu High Resolution Micro-Ultrasound System, Exact Imaging, Inc. (2019) Summary page 5.

## Indications for use
The ExactVu High Resolution Micro-Ultrasound System is intended for use by qualified physicians, physician assistants, sonographers and ultrasound technicians in a healthcare facility for diagnostic ultrasound imaging or fluid flow analysis of the human body in B-Mode (2D), Color Flow Imaging Modes (Color Doppler and Power Doppler) and Combined (B-Mode + CFI Modes). The indications for use 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/K192303
Methodology: https://510kreport.com/methodology