# K181313: BenQ Diagnostic Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: Qisda Corporation
- Decided: Aug 27, 2018 after 102 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: 19 generations back to K935595 (1995). 145 ancestors in all.
1 later device descends 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)
- K172056: InnoSight Diagnostic Ultrasound System, Qisda Corporation (2017) Summary page 8.

## Most influential descendants
- K192254: InnoSight Diagnostic Ultrasound System (2019), 0 descendants of its own

## Indications for use
The system is a general-purpose ultrasonic imaging instrument intended for use by a qualified physician for ultrasound evaluation/clinical analysis etc. It can be used in non-intrusive applications, including Abdomen, Cardiology, Gynecology, Obstetric, Breast, Thyroid, Musculoskeletal, Vascular (Carotid, Venous, Arterial), Nerve, Renal, and Urology. The clinical environments where the system can be used include clinics, hospitals, and clinical point of care for diagnosis of patients. 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/K181313
Methodology: https://510kreport.com/methodology