# K163121: SmartUs EXT-1M/3M

- Pathway: 510(k) (Traditional)
- Applicant: Telemed
- Decided: Aug 10, 2017 after 275 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: 15 generations back to K924432 (1993). 27 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 30 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K113184: Logicscan 64 Logicscan 128, Telemed (2012) Summary page 8.
- K112646: Sonoace R7 Diagnostic Ultrasound System, Samsung Medison Co., Ltd. (2011) Summary page 8.

## Most influential descendants
- K211248: ArtUs (2022), 0 descendants of its own
- K181124: Acessa ProVu System (2018), 0 descendants of its own

## Indications for use
SmartUs EXT-1M/3M ultrasound imaging system is intended to be used for applications in fetal, abdominal, pediatric, small organ (breast, thyroid, testicles), adult cefalic, musculo-skeletal (conventional), musculo-skeletal (superficial), cardiac adult, cardiac pediatric, peripheral vessel (B and M-mode, combined modes imaging, including imaging for needle guidance). It is possible to provide diagnostic information outside of an imaging lab, including at thebedside systems, for navigatedmedical application, in operating rooms/critical care units.

Source page: https://510kreport.com/device/K163121
Methodology: https://510kreport.com/methodology