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FDA 510(k)

ExactVu High Resolution Micro-Ultrasound System

K-Number: K180636 · 2018-04-30

ApplicantExact Imaging, Inc.
Decision Date2018-04-30
Product CodeIYO
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 2018-04-30 under approval number K180636. 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 2018-04-30. It is manufactured by Exact Imaging, Inc.. The 510(k) number is K180636.

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

ExactVu High Resolution Micro-Ultrasound System received FDA 510(k) clearance on 2018-04-30, under approval number K180636.

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 IYO.

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Other Devices by Exact Imaging, Inc.

K192303ExactVu High Resolution Micro-Ultrasound System K190995ExactVu High Resolution Micro-Ultrasound System

Related Devices (Code: IYO)

K162972ExactVu High Resolution Micro-Ultrasound SystemExact Imaging K161968MicrUsTelemed K161342Sonic WindowAnalogic Corporation K161300Acclarix AX8 Diagnostic Ultrasound SystemEdan Instruments, Inc. K153620Enovare Ultrasound SystemOreon Technologies, Inc. K160792Morpheus RealTime Ultrasound, Pathway RealTime Ultrasound, QuickScan Bladder UltrasoundThe Prometheus Group

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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