Lumify Diagnostic Ultrasound System

The Lumify Diagnostic Ultrasound System is a portable, software-controlled medical device that acquires and displays ultrasound data in B-mode (2D), Pulsed Wave Doppler, Color Doppler, Combined (B+Color), and M-modes. It is intended for diagnostic ultrasound imaging and fluid flow analysis across multiple clinical applications (fetal/obstetric, abdominal, cardiac, musculoskeletal, etc.) and is designed for use by qualified healthcare professionals in clinical environments.

The subject device adds a new software function called FAST Auto Assist, which provides real-time detection and labeling of abdominal organs and zones (LUQ, RUQ, Supra-Pubic) during FAST exams using artificial intelligence algorithms. The core system architecture remains unchanged; this is a software-only addition compatible with Android devices for adult patients (age ≥18). Only the S4-1 and C5-2 transducers work with the FAST Auto Assist feature.

The device complies with FDA's ultrasound guidance document 'Marketing Clearance of Diagnostic Ultrasound Systems and Transducers' (February 21, 2023) and reference standards including IEC 60601-1 and IEC 60601-2-37. Non-clinical verification testing included requirements review, risk analysis, design reviews, and retrospective data analysis of artificial intelligence algorithm performance.

The subject device is substantially equivalent to the primary predicate K223771 (Lumify Diagnostic Ultrasound System) because it maintains identical indications for use, intended use, modes of operation, user environment, and transducers (S4-1, C5-2), with no changes affecting device safety or effectiveness. The addition of FAST Auto Assist is a software-only feature that does not modify patient contact materials, hardware, or the underlying ultrasound acquisition and display functionality, and performance testing demonstrates high accuracy (86.0% overall) and safety comparable to predicate devices.