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FDA 510(k)

DUS-7000 Digital Color Doppler Ultrasound System

K-Number: K172055 · 2017-08-31

ApplicantAdvanced Instrumentations, Inc.
Decision Date2017-08-31
Product CodeIYN
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

DUS-7000 Digital Color Doppler Ultrasound System is a medical device manufactured by Advanced Instrumentations, Inc.. It received FDA 510(k) clearance on 2017-08-31 under approval number K172055. 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 DUS-7000 Digital Color Doppler Ultrasound System?

DUS-7000 Digital Color Doppler Ultrasound System is a medical device that received FDA 510(k) clearance on 2017-08-31. It is manufactured by Advanced Instrumentations, Inc.. The 510(k) number is K172055.

When was DUS-7000 Digital Color Doppler Ultrasound System approved by the FDA?

DUS-7000 Digital Color Doppler Ultrasound System received FDA 510(k) clearance on 2017-08-31, under approval number K172055.

What company makes DUS-7000 Digital Color Doppler Ultrasound System?

DUS-7000 Digital Color Doppler Ultrasound System is manufactured by Advanced Instrumentations, Inc..

What is the FDA product code for DUS-7000 Digital Color Doppler Ultrasound System?

The FDA product code for DUS-7000 Digital Color Doppler Ultrasound System is IYN.

Related Clinical Trials

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Related PubMed Literature

PMID: 33371797 Developing a Qualification and Verification Strategy for Digital Tissue Image Analysis in Toxicological Pathology. Toxicologic pathology (2021)

Other Devices by Advanced Instrumentations, Inc.

K172931DUS-6000 Digital Ultrasonic Diagnostic Imaging System

Related Devices (Code: IYN)

K162845DC-40/DC-35/DC-45/DC-40S/DC-40 Pro Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. K162902ARIETTA Prologue Diagnostic Ultrasound system and TransducersHitachi , Ltd. K163138Clarius Ultrasound SystemClarius Mobile Health Corp. K163077LOGIQ E9, LOGIQ E9 XDClear 2.0GE Medical Systems Ultrasound and Primary Care Diagnostics K162583ALOKA LISENDO 880Hitachi , Ltd. K163020Xperius Ultrasound SystemPhilips Health Care

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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