X5 Series Digital Color Doppler Ultrasound System
K-Number: K182648 · 2019-01-29
ApplicantSonoscape Medical Corp.
Decision Date2019-01-29
Product CodeIYN
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
X5 Series Digital Color Doppler Ultrasound System is a medical device manufactured by Sonoscape Medical Corp.. It received FDA 510(k) clearance on 2019-01-29 under approval number K182648. 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 X5 Series Digital Color Doppler Ultrasound System?
X5 Series Digital Color Doppler Ultrasound System is a medical device that received FDA 510(k) clearance on 2019-01-29. It is manufactured by Sonoscape Medical Corp.. The 510(k) number is K182648.
When was X5 Series Digital Color Doppler Ultrasound System approved by the FDA?
X5 Series Digital Color Doppler Ultrasound System received FDA 510(k) clearance on 2019-01-29, under approval number K182648.
What company makes X5 Series Digital Color Doppler Ultrasound System?
X5 Series Digital Color Doppler Ultrasound System is manufactured by Sonoscape Medical Corp..
What is the FDA product code for X5 Series Digital Color Doppler Ultrasound System?
The FDA product code for X5 Series Digital Color Doppler 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.