ExactVu High Resolution Micro-Ultrasound System
K-Number: K192303 · 2019-10-01
ApplicantExact Imaging, Inc.
Decision Date2019-10-01
Product CodeIYN
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
ExactVu High Resolution Micro-Ultrasound System is a medical device manufactured by Exact Imaging, Inc.. It received FDA 510(k) clearance on 2019-10-01 under approval number K192303. 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 ExactVu High Resolution Micro-Ultrasound System?
ExactVu High Resolution Micro-Ultrasound System is a medical device that received FDA 510(k) clearance on 2019-10-01. It is manufactured by Exact Imaging, Inc.. The 510(k) number is K192303.
When was ExactVu High Resolution Micro-Ultrasound System approved by the FDA?
ExactVu High Resolution Micro-Ultrasound System received FDA 510(k) clearance on 2019-10-01, under approval number K192303.
What company makes ExactVu High Resolution Micro-Ultrasound System?
ExactVu High Resolution Micro-Ultrasound System is manufactured by Exact Imaging, Inc..
What is the FDA product code for ExactVu High Resolution Micro-Ultrasound System?
The FDA product code for ExactVu High Resolution Micro-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.