# K152899: Philips Lumify Diagnostic Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: Philips Healthcare, Inc.
- Decided: Oct 30, 2015 after 29 days
- Product code: IYN (System, Imaging, Pulsed Doppler, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1550
- Recalls of this device: 4 (0 Class I)
- 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.
79 later devices descend from it; 5 cite it directly.
8 of 252 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 4.

## Most influential descendants
- 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
- K201012: EPIQ Diagnostic Ultrasound System Series, Affiniti Diagnostic Ultrasound System Series, CX50 Diagnostic Ultrasound System, Sparq Diagnostic Ultrasound System, Lumify Diagnostic Ultrasound System (2020), 18 descendants of its own

## Recalls of this device
- Jul 3, 2025 · Class III · Z-2373-2025: To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
- 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-2374-2025: To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
- Dec 9, 2015 · Class II · Z-0596-2016: Color Flow direction is displayed incorrectly in Lumify 1.0. The system displayed Color Flow direction does not correctly represent the annotated Color Bar or Velocity Markers. (e.g.) When the Color B

## Indications for use
Philips Lumify 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 Fetal/Obstetric Abdominal Urology Gynecological Cardiac Fetal Echo Small Organ Musculo-skeletal Peripheral Vessel Carotid Lumify is intended for use in environments where healthcare is provided by healthcare professionals, with the exception of home, ambulance or air.

Source page: https://510kreport.com/device/K152899
Methodology: https://510kreport.com/methodology