X3 Exp/X3/X3 Pro/X1 Pro/X1 Digital Color Doppler Ultrasound System
K-Number: K163427 · 2017-01-03
ApplicantSonoscape Medical Corp.
Decision Date2017-01-03
Product CodeIYN
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
X3 Exp/X3/X3 Pro/X1 Pro/X1 Digital Color Doppler Ultrasound System is a medical device manufactured by Sonoscape Medical Corp.. It received FDA 510(k) clearance on 2017-01-03 under approval number K163427. 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 X3 Exp/X3/X3 Pro/X1 Pro/X1 Digital Color Doppler Ultrasound System?
X3 Exp/X3/X3 Pro/X1 Pro/X1 Digital Color Doppler Ultrasound System is a medical device that received FDA 510(k) clearance on 2017-01-03. It is manufactured by Sonoscape Medical Corp.. The 510(k) number is K163427.
When was X3 Exp/X3/X3 Pro/X1 Pro/X1 Digital Color Doppler Ultrasound System approved by the FDA?
X3 Exp/X3/X3 Pro/X1 Pro/X1 Digital Color Doppler Ultrasound System received FDA 510(k) clearance on 2017-01-03, under approval number K163427.
What company makes X3 Exp/X3/X3 Pro/X1 Pro/X1 Digital Color Doppler Ultrasound System?
X3 Exp/X3/X3 Pro/X1 Pro/X1 Digital Color Doppler Ultrasound System is manufactured by Sonoscape Medical Corp..
What is the FDA product code for X3 Exp/X3/X3 Pro/X1 Pro/X1 Digital Color Doppler Ultrasound System?
The FDA product code for X3 Exp/X3/X3 Pro/X1 Pro/X1 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.