Lumify Diagnostic Ultrasound System
K-Number: K192226 · 2019-09-06
ApplicantPhilips Health Care
Decision Date2019-09-06
Product CodeIYN
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
Lumify Diagnostic Ultrasound System is a medical device manufactured by Philips Health Care. It received FDA 510(k) clearance on 2019-09-06 under approval number K192226. 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 2019-09-06. It is manufactured by Philips Health Care. The 510(k) number is K192226.
When was Lumify Diagnostic Ultrasound System approved by the FDA?
Lumify Diagnostic Ultrasound System received FDA 510(k) clearance on 2019-09-06, under approval number K192226.
What company makes Lumify Diagnostic Ultrasound System?
Lumify Diagnostic Ultrasound System is manufactured by Philips Health Care.
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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Other Devices by Philips Health Care
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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.