# K203406: Lumify Diagnostic Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: Philips Ultrasound, Inc.
- Decided: Feb 23, 2021 after 96 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: 20 generations back to K935595 (1995). 175 ancestors in all.
4 later devices descend from it; 2 cite it directly.
6 of 180 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 5.

## Most influential descendants
- K223771: Lumify Diagnostic Ultrasound System (2023), 2 descendants of its own
- K252558: Lumify Diagnostic Ultrasound System (2026), 0 descendants of its own
- K251268: Diagnostic Ultrasound System (Nano C5, Nano C5 EXP, Nano L12, and Nano L12 EXP) (2025), 0 descendants of its own
- K252557: Lumify Diagnostic Ultrasound System (2025), 0 descendants of its own

## 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.
- Jul 3, 2025 · Class III · Z-2374-2025: To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
- Jul 3, 2025 · Class III · Z-2392-2025: To provide clarification and labelling to define the useful life of ultrasound transducers in the field.

## Indications for use
Philips Lumify Diagnostic Ultrasound System is intended for diagnostic ultrasound imaging in B (2D), Color Doppler, Combined (B+Color), 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. Lumify is a transportable ultrasound system intended for use in environments where healthcare is provided by healthcare professionals.

Source page: https://510kreport.com/device/K203406
Methodology: https://510kreport.com/methodology