# K172056: InnoSight Diagnostic Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: Qisda Corporation
- Decided: Dec 13, 2017 after 160 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: 18 generations back to K935595 (1995). 144 ancestors in all.
2 later devices descend from it; 1 cites it directly.
6 of 147 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K132690: UP600 Diagnostic Doppler Ultrasound System, Qisda Corporation (2014) Summary page 4.
- K162329: CX50 Diagnostic Ultrasound System, Sparq Diagnostic Ultrasound System, Philips Health Care (2016) Summary page 4.

## Most influential descendants
- K181313: BenQ Diagnostic Ultrasound System (2018), 1 descendant of its own
- K192254: InnoSight Diagnostic Ultrasound System (2019), 0 descendants of its own

## Indications for use
InnoSight Diagnostic Ultrasound System is intended for diagnostic ultrasound imaging in B (2D), M-Mode, PW Doppler, CPA, Tissue Harmonic imaging and Color Doppler modes. It is indicated for diagnostic ultrasound imaging and fluid flow analysis in the following applications: Fetal, Abdominal, Small Organ (Breast, Thyroid, testes), trans-rectal, trans-vaginal, Other (OB/GYN, Urology, Nerve), Cardiac Adult and Peripheral Vessel. The clinical environments where the system can be used include clinics, hospitals, and clinical point-of-care for diagnosis of patients.

Source page: https://510kreport.com/device/K172056
Methodology: https://510kreport.com/methodology