# K162972: ExactVu High Resolution Micro-Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: Exact Imaging
- Decided: Dec 2, 2016 after 38 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: 4 generations back to K000567 (2000). 6 ancestors in all.
3 later devices descend 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)
- K081154: Ultrasound Scanner Flex Focus, Model 1202, B-K Medical Aps (2008) Summary page 9.

## Most influential descendants
- K180636: ExactVu High Resolution Micro-Ultrasound System (2018), 2 descendants of its own
- K190995: ExactVu High Resolution Micro-Ultrasound System (2019), 1 descendant of its own
- K192303: ExactVu High Resolution Micro-Ultrasound System (2019), 0 descendants of its own

## Indications for use
The ExactVu High Resolution Micro-Ultrasound System is intended for use by qualified medical professionals for diagnostic ultrasound imaging or fluid flow analysis of the human body; the intended uses are: Small Organ (prostate) Transrectal The system may be used with patients of all ages, but is not designed for pediatric or fetal use.

Source page: https://510kreport.com/device/K162972
Methodology: https://510kreport.com/methodology