# K133833: Nuvis Diagnostic Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: Philips Ultrasound, Inc.
- Decided: Jan 17, 2014 after 31 days
- Product code: IYN (System, Imaging, Pulsed Doppler, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1550
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 16 generations back to K935595 (1995). 171 ancestors in all.
87 later devices descend from it; 3 cite it directly.
8 of 259 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120321: Clearvue 350/550 Diagnostic Ultrasound System, Philips Health Care (2012) Summary page 1.
- K132304: Epiq Diagnostic Ultrasound System, Philips Ultrasound, Inc. (2013) Summary page 1.
- K070907: Interson Usb Ultrasound Probe System, Regulatory Management Services (2007) Summary page 1.
- K102153: Mobius Ultrasound Imaging System, Mobisante, Inc. (2011) Summary page 1.

## Most influential descendants
- K152899: Philips Lumify Diagnostic Ultrasound System (2015), 79 descendants of its own
- K162549: Lumify Ultrasound System (2016), 43 descendants of its own
- K192226: Lumify Diagnostic Ultrasound System (2019), 31 descendants of its own
- K163138: Clarius Ultrasound System (2016), 28 descendants of its own
- K172385: Clarius Ultrasound System (2017), 22 descendants of its own

## Recalls of this device
- Jul 3, 2025 · Class III · Z-2354-2025: To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
- Jul 3, 2025 · Class III · Z-2353-2025: To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
- May 28, 2025 · Class II · Z-2050-2025: Ultrasound transducer devices were refurbished beyond their useful life.

## Indications for use
Philips Nuvis Diagnostic Ultrasound system is intended for diagnostic ultrasound imaging in B (2D), Color Doppler. and Combined (B + Color) modes. It is indicated for diagnostic ultrasound imaging and fluid flow analysis in the following applications: Fetal/Obstetric Abdominal Other (Urology) Other (Gynecology) Other Cardiac (Fetal Echo) The clinical environments where the Nuvis Diagnostic Ultrasound system can be used include hospital, clinical and medical office settings for the diagnosis of patients.

Source page: https://510kreport.com/device/K133833
Methodology: https://510kreport.com/methodology