# K252558: Lumify Diagnostic Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: Philips Ultrasound, LLC
- Decided: May 5, 2026 after 265 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: 22 generations back to K935595 (1995). 178 ancestors in all.
No later device cites it as a predicate yet.
6 of 179 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K223771: Lumify Diagnostic Ultrasound System, Philips Ultrasound (2023) Summary page 7.
- K233826: Kosmos, EchoNous, Inc. (2024) Summary page 7.

## 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, 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. The Lumify Diagnostic Ultrasound System is intended to be used by qualified and trained healthcare professionals.

Source page: https://510kreport.com/device/K252558
Methodology: https://510kreport.com/methodology