Philips Ultrasound, LLC · Class II · Cleared Apr 28, 2025
| K-number | K250030 |
| Device name | Flash Ultrasound System 5100 Point of Care |
| Applicant | Philips Ultrasound, LLC |
| Product code | IYN |
| Device class | Class II |
| Decision date | Apr 28, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 892.1550 |
The Flash Ultrasound System 5100 Point of Care is a diagnostic ultrasound imaging system designed for point-of-care environments such as emergency rooms, hospitals, and clinics. It performs diagnostic ultrasound imaging and fluid flow analysis across multiple anatomical applications including abdominal, cardiac, peripheral vessel, and obstetric imaging, operating in B-mode, Doppler, M-mode, and harmonic imaging modes.
The device combines the previously cleared 5000 Compact Series hardware platform with a new Rhythm software platform designed for point-of-care workflows. Key design features include a full touchscreen interface, compact footprint optimized for emergency room spaces, assisted needle visualization, AutoStrain EF functionality, and ergonomic vertical tablet controls. The device supports the same transducers as predicate systems (C5-1, C6-2, C8-5, C9-4V, L12-3ERGO, eL18-4, mL26-8, S5-1, S8-3, X7-2t, X8-2t), with two models distinguished by transducer support capabilities.
IEC 60601-1:2005+AMD1:2012+AMD2:2020 (medical electrical equipment general requirements), IEC 60601-1-2:2014+AMD1:2020 (electromagnetic compatibility), IEC 60601-2-37:2024 (ultrasonic diagnostic equipment), IEC 62304:2006+AMD1:2015 (software lifecycle), IEC 62359:2010+AMD1:2017 (ultrasonic field characterization), IEC 62366-1:2015+AMD1:2020 (usability engineering), and ISO 14971:2019 (risk management).
Substantial equivalence is based on identical indications for use and intended users/environments compared to the predicate Sparq system (K162329). The new Rhythm software platform is considered functionally equivalent to the predicate's software despite being new to the POC environment. No new transducers are introduced and all transducers' indications already exist on cleared Philips systems. Non-clinical performance testing demonstrates the user interface is safe and effective for intended uses, and design changes do not introduce new or significantly modified risks to safety or effectiveness.
View the full FDA submission: accessdata.fda.gov