# K232500: Lumify Diagnostic Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: Philips Ultrasound
- Decided: Oct 26, 2023 after 70 days
- Product code: IYN (System, Imaging, Pulsed Doppler, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1550
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 19 generations back to K935595 (1995). 174 ancestors in all.
No later device cites it as a predicate yet.
6 of 175 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K162549: Lumify Ultrasound System, Philips Health Care (2016) Summary page 6.

## Recalls of this device
- Oct 31, 2025 · Class II · Z-0883-2026: Ultrasound system compatibility issues with Apple devices running iOS 18 may cause a failure to perform live imagining.

## Indications for use
The Philips Lumify Diagnostic Ultrasound System is intended for diagnostic ultrasound imaging in B (2D), Color Doppler, Combined (B+Color), Pulsed Wave Doppler (PWD), and M-modes. It is indicated for diagnostic ultrasound imaging and fluid flow analysis in the following applications: Fetal/Obstetric,Abdominal, Pediatric, Cephalic, Urology, Gynecological, Cardiac Fetal Echo, Small Organ,Musculoskeletal, Peripheral Vessel, Carotid, Cardiac, Lung. The Lumify system is a transportable ultrasound system intended for use in environments where healthcare is provided by healthcare professionals.

Source page: https://510kreport.com/device/K232500
Methodology: https://510kreport.com/methodology