# K141369: Visiq Diagnostic Ultra Sound System

- Pathway: 510(k) (Traditional)
- Applicant: Philips Ultrasound, Inc.
- Decided: Jul 2, 2014 after 40 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: 17 generations back to K935595 (1995). 172 ancestors in all.
No later device cites it as a predicate yet.
6 of 173 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133833: Nuvis Diagnostic Ultrasound System, Philips Ultrasound, Inc. (2014) Summary page 1.
- K120321: Clearvue 350/550 Diagnostic Ultrasound System, Philips Health Care (2012) Summary page 1.

## Indications for use
Philips VISIQ Diagnostic Ultrasound system is intended for diagnostic ultrasound imaging in 2D Auto Scan, MV-mode, Pulse Wave Doppler, Color Doppler, Tissue Harmonics &iSCAN. The system is indicated for diagnostic ultrasound imaging and fluid flow analysis and supports the following Indications for Use: Abdominal, Cardiac other (Fetal), Fetal/Obstetric, Gynecological, and Small Organ (Prostate). The clinical environments where the VISIQ. Diagnostic Ultrasound system can be used include large/small hospitals, clinical and medical office settings, and primary and community healthcare centers for the diagnosis of patients. Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Diagnostic ultrasound imaging or fuid flow analysis of the human body as follows:

Source page: https://510kreport.com/device/K141369
Methodology: https://510kreport.com/methodology