Lumify Diagnostic Ultrasound System
K-Number: K252558 · 2026-05-05
ApplicantPhilips Ultrasound, LLC
Decision Date2026-05-05
Product CodeIYN
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
Lumify Diagnostic Ultrasound System is a medical device manufactured by Philips Ultrasound, LLC. It received FDA 510(k) clearance on 2026-05-05 under approval number K252558. 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 Lumify Diagnostic Ultrasound System?
Lumify Diagnostic Ultrasound System is a medical device that received FDA 510(k) clearance on 2026-05-05. It is manufactured by Philips Ultrasound, LLC. The 510(k) number is K252558.
When was Lumify Diagnostic Ultrasound System approved by the FDA?
Lumify Diagnostic Ultrasound System received FDA 510(k) clearance on 2026-05-05, under approval number K252558.
What company makes Lumify Diagnostic Ultrasound System?
Lumify Diagnostic Ultrasound System is manufactured by Philips Ultrasound, LLC.
What is the FDA product code for Lumify Diagnostic Ultrasound System?
The FDA product code for Lumify Diagnostic Ultrasound System is IYN.
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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.