Lumify Diagnostic Ultrasound System

The Lumify Diagnostic Ultrasound System is a portable, software-controlled ultrasound device that runs on iOS and Android mobile devices and uses USB transducers to acquire and display high-resolution ultrasound images in B mode (2D), Color Doppler, Pulsed Wave Doppler, and M modes. It is intended for diagnostic ultrasound imaging and fluid flow analysis across multiple clinical applications including fetal/obstetric, abdominal, cardiac, vascular, musculoskeletal, and ophthalmic imaging, for use by healthcare professionals in clinical settings.

The subject device adds an Ocular preset (imaging setting for the eye) to the previously cleared L12-4 linear array transducer, expanding the system's clinical indications to include Ophthalmic imaging. The Ocular preset supports 2D (B Mode) and Color Doppler Mode. All other technological characteristics—regulation number, device classification, product codes, transducer types, operating system compatibility, and imaging modes—remain unchanged from the predicate device.

IEC 62304 (Medical device software – Software life cycle processes, 2006 + A 2015); IEC 62366-1 (Medical devices – Application of usability engineering to medical devices, 2015); ISO 14971 (Medical devices – Application of risk management to medical devices, 2019); FDA guidance document 'Marketing Clearance of Diagnostic Ultrasound Systems and Transducers' (February 21, 2023).

Substantial equivalence is based on the fact that the Ophthalmic indication with the Ocular preset is not new to ultrasound systems—it is already cleared on the reference Sparq Diagnostic Ultrasound System (K162329) using the same L12-4 transducer type. The modification involves only a software preset and clinical indication addition to an existing, previously cleared transducer; the underlying technology, imaging modes, and transducer hardware remain identical. Non-clinical performance testing confirmed the system meets its intended use specifications, and no new safety or effectiveness questions are raised by adding a preset and indication already established in the Sparq system.