# K192254: InnoSight Diagnostic Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: Qisda Corporation
- Decided: Sep 18, 2019 after 29 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: 20 generations back to K935595 (1995). 146 ancestors in all.
No later device cites it as a predicate yet.
6 of 147 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K162329: CX50 Diagnostic Ultrasound System, Sparq Diagnostic Ultrasound System, Philips Health Care (2016) Summary page 10.
- K181313: BenQ Diagnostic Ultrasound System, Qisda Corporation (2018) Summary page 19.

## Indications for use
InnoSight Diagnostic Ultrasound System is intended for diagnostic ultrasound imaging in B (2D), M-Mode, PW and CW Spectral 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, Pediatric, Small Organ (breast, thyroid, testes), Adult Cephalic, Trans-rectal, Trans-vaginal, Musculo-skel. (Conventional), Other (Ob/GYN, Urology, Nerve), Cardiac Adult, Cardiac Pediatric, Peripheral Vessel and Carotid. The clinical environments where the system can be used include physician offices, clinics, hospitals, and clinical point-of-care for diagnosis of patients except environments where the intensity of electromagnetic disturbances is high. The system is intended to be installed, used, and operated only in accordance with the safety procedures and operating instructions given in the system user information, and only for the purposes for which it was designed. The system should only be operated by someone who has received proper training in the use and operation of an ultrasound system. This system produces images derived from sound echoes; those images must be interpreted by a qualified medical professional. This system in no way interprets these images or provides a medical diagnosis of the patient being examined.

Source page: https://510kreport.com/device/K192254
Methodology: https://510kreport.com/methodology