# K113184: Logicscan 64 Logicscan 128

- Pathway: 510(k) (Traditional)
- Applicant: Telemed
- Decided: Jan 26, 2012 after 90 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: 14 generations back to K924432 (1993). 26 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 31 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K100186: Mysono U5 Diagnostic Ultrasound System, Medison Co., Ltd. (2010) Summary page 1.
- K112646: Sonoace R7 Diagnostic Ultrasound System, Samsung Medison Co., Ltd. (2011) Summary page 1.

## Most influential descendants
- K163121: SmartUs EXT-1M/3M (2017), 2 descendants of its own
- K211248: ArtUs (2022), 0 descendants of its own
- K181124: Acessa ProVu System (2018), 0 descendants of its own
- K173486: NTU-USB Ultrasound USB Box (2018), 0 descendants of its own

## Indications for use
The LogicScan 64 ILogicScan 128 systems and transducers are intended for diagnostic ultrasound imaging and fluid analysis of the human body. The applications are: cardiac (adult), fetal, abdominal, pediatric, small organ, transrectal, neonatal cephalic, peripheral vessel and musculo-skeletal (conventional and superficial). 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/K113184
Methodology: https://510kreport.com/methodology