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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 the device name listed in this FDA 510(k) record. The listed applicant is Exact Imaging. It received FDA 510(k) clearance on 2016-12-02 under 510(k) 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. The listed applicant is Exact Imaging. The 510(k) number is K162972.

When did ExactVu High Resolution Micro-Ultrasound System receive FDA 510(k) clearance?

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

Who is the listed applicant for ExactVu High Resolution Micro-Ultrasound System?

The FDA 510(k) record lists Exact Imaging as the applicant. This does not by itself establish the device manufacturer.

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.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT02748941Carotid Atherosclerosis : Innovative Imaging Biomarkers. Study Case-controlRECRUITINGNCT06626022Screening for Prostate Cancer Using High Resolution Micro-ultrasound Versus Multiparametric Magnetic Resonance Imaging.RECRUITING

Other records listing Exact Imaging as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K192303ExactVu High Resolution Micro-Ultrasound SystemK190995ExactVu High Resolution Micro-Ultrasound SystemK180636ExactVu High Resolution Micro-Ultrasound System

Related Devices (Code: IYO)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253452Accuro 3SRivanna Medical, Inc.K260190ARTHURROPCA ApSK252237EdgeFlow UW20Edgecare, Inc.K254021Accuro XVRivanna Medical, Inc.K253898QT Scanner 2000 Model AQT Imaging Holdings, Inc.K253714IntraSight PlusPhilips Image Guided Therapy Corporation

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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