CX50 Diagnostic Ultrasound System, Sparq Diagnostic Ultrasound System
K-Number: K162329 · 2016-09-14
ApplicantPhilips Health Care
Decision Date2016-09-14
Product CodeIYN
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
CX50 Diagnostic Ultrasound System, Sparq Diagnostic Ultrasound System is a medical device manufactured by Philips Health Care. It received FDA 510(k) clearance on 2016-09-14 under approval number K162329. 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 CX50 Diagnostic Ultrasound System, Sparq Diagnostic Ultrasound System?
CX50 Diagnostic Ultrasound System, Sparq Diagnostic Ultrasound System is a medical device that received FDA 510(k) clearance on 2016-09-14. It is manufactured by Philips Health Care. The 510(k) number is K162329.
When was CX50 Diagnostic Ultrasound System, Sparq Diagnostic Ultrasound System approved by the FDA?
CX50 Diagnostic Ultrasound System, Sparq Diagnostic Ultrasound System received FDA 510(k) clearance on 2016-09-14, under approval number K162329.
What company makes CX50 Diagnostic Ultrasound System, Sparq Diagnostic Ultrasound System?
CX50 Diagnostic Ultrasound System, Sparq Diagnostic Ultrasound System is manufactured by Philips Health Care.
What is the FDA product code for CX50 Diagnostic Ultrasound System, Sparq Diagnostic Ultrasound System?
The FDA product code for CX50 Diagnostic Ultrasound System, Sparq 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.