X5 Digital Color Doppler Ultrasound System
K-Number: K160258 · 2016-04-01
ApplicantSonoscape Medical Corp.
Decision Date2016-04-01
Product CodeIYN
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
X5 Digital Color Doppler Ultrasound System is a medical device manufactured by Sonoscape Medical Corp.. It received FDA 510(k) clearance on 2016-04-01 under approval number K160258. 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 Digital Color Doppler Ultrasound System?
X5 Digital Color Doppler Ultrasound System is a medical device that received FDA 510(k) clearance on 2016-04-01. It is manufactured by Sonoscape Medical Corp.. The 510(k) number is K160258.
When was X5 Digital Color Doppler Ultrasound System approved by the FDA?
X5 Digital Color Doppler Ultrasound System received FDA 510(k) clearance on 2016-04-01, under approval number K160258.
What company makes X5 Digital Color Doppler Ultrasound System?
X5 Digital Color Doppler Ultrasound System is manufactured by Sonoscape Medical Corp..
What is the FDA product code for X5 Digital Color Doppler Ultrasound System?
The FDA product code for X5 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.