# K161968: MicrUs

- Pathway: 510(k) (Traditional)
- Applicant: Telemed
- Decided: Nov 3, 2016 after 108 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: 6 generations back to K944485 (1995). 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)
- K102253: Echo Blaster, Telemed (2011) Summary page 10.

## Indications for use
MicrUs ultrasound imaging system is intended to be used for applications in fetal, abdominal, pediatric, small organ (breast, thyroid, testicles), neonatal cephalic, adult cephalic, musculo-skeletal (conventional), musculo-skeletal (superficial), cardiac adult, peripheral vessel (B and M-mode imaging, including imaging for needle guidance). It is possible to provide diagnostic information outside of an imaging lab, including at the bedside systems, for navigated medical application, in operating rooms/critical care units.

Source page: https://510kreport.com/device/K161968
Methodology: https://510kreport.com/methodology