# K242670: Lumify Diagnostic Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: Philips Ultrasound
- Decided: May 8, 2025 after 245 days
- Product code: IYN (System, Imaging, Pulsed Doppler, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1550
- Recalls of this device: 2 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 20 generations back to K935595 (1995). 175 ancestors in all.
No later device cites it as a predicate yet.
7 of 176 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K192226: Lumify Diagnostic Ultrasound System, Philips Health Care (2019) Summary page 7.

## Recalls of this device
- Sep 24, 2026 · Class I · Z-0152-2027: Ultrasound system may: 1) Not recognize previous transducer registration, prevent scanning, require re-registration with Wi-Fi/cellular access, which may be unavailable outside of the hospital (ambula
- 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, Ophthalmic. 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/K242670
Methodology: https://510kreport.com/methodology