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FDA 510(k)

ExactVu High Resolution Micro-Ultrasound System

K-Number: K162972 · 2016-12-02

ApplicantExact Imaging
Decision Date2016-12-02
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ExactVu High Resolution Micro-Ultrasound System is a medical device manufactured by Exact Imaging. It received FDA 510(k) clearance on 2016-12-02 under approval number K162972. The device is classified under product code IYO. 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 2016-12-02. It is manufactured by Exact Imaging. The 510(k) number is K162972.

When was ExactVu High Resolution Micro-Ultrasound System approved by the FDA?

ExactVu High Resolution Micro-Ultrasound System received FDA 510(k) clearance on 2016-12-02, under approval number K162972.

What company makes ExactVu High Resolution Micro-Ultrasound System?

ExactVu High Resolution Micro-Ultrasound System is manufactured by Exact Imaging.

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 IYO.

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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.

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