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FDA 510(k)

Flash Ultrasound System 5100 Point of Care

K-Number: K250030 · 2025-04-28

ApplicantPhilips Ultrasound, LLC
Decision Date2025-04-28
Product CodeIYN
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Flash Ultrasound System 5100 Point of Care is a medical device manufactured by Philips Ultrasound, LLC. It received FDA 510(k) clearance on 2025-04-28 under approval number K250030. The device is classified under product code IYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Flash Ultrasound System 5100 Point of Care?

Flash Ultrasound System 5100 Point of Care is a medical device that received FDA 510(k) clearance on 2025-04-28. It is manufactured by Philips Ultrasound, LLC. The 510(k) number is K250030.

When was Flash Ultrasound System 5100 Point of Care approved by the FDA?

Flash Ultrasound System 5100 Point of Care received FDA 510(k) clearance on 2025-04-28, under approval number K250030.

What company makes Flash Ultrasound System 5100 Point of Care?

Flash Ultrasound System 5100 Point of Care is manufactured by Philips Ultrasound, LLC.

What is the FDA product code for Flash Ultrasound System 5100 Point of Care?

The FDA product code for Flash Ultrasound System 5100 Point of Care is IYN.

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Other Devices by Philips Ultrasound, LLC

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Related Devices (Code: IYN)

K162845DC-40/DC-35/DC-45/DC-40S/DC-40 Pro Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. K162902ARIETTA Prologue Diagnostic Ultrasound system and TransducersHitachi , Ltd. K163138Clarius Ultrasound SystemClarius Mobile Health Corp. K163077LOGIQ E9, LOGIQ E9 XDClear 2.0GE Medical Systems Ultrasound and Primary Care Diagnostics K162583ALOKA LISENDO 880Hitachi , Ltd. K163020Xperius Ultrasound SystemPhilips Health Care

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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