# K173486: NTU-USB Ultrasound USB Box

- Pathway: 510(k) (Traditional)
- Applicant: National Taiwan University
- Decided: Jul 11, 2018 after 240 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.
No later device cites it as a predicate yet.
0 of 28 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 6.

## Indications for use
The NTU-USB ultrasound USB box is a general ultrasound imaging system intended for use by a qualified physician or sonographer for clinical diagnosis. Specific clinical applications and exam types include: 1. Small Organ (Breast) 2. Peripheral Vessel

Source page: https://510kreport.com/device/K173486
Methodology: https://510kreport.com/methodology