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 the device name listed in this FDA 510(k) record. The listed applicant is Advanced Instrumentations, Inc.. It received FDA 510(k) clearance on 2017-08-31 under 510(k) 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. The listed applicant is Advanced Instrumentations, Inc.. The 510(k) number is K172055.

When did DUS-7000 Digital Color Doppler Ultrasound System receive FDA 510(k) clearance?

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

Who is the listed applicant for DUS-7000 Digital Color Doppler Ultrasound System?

The FDA 510(k) record lists Advanced Instrumentations, Inc. as the applicant. This does not by itself establish the device manufacturer.

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

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.

NCT06861309Placental Imaging TechniquesRECRUITING NCT07012655Color Doppler Ultrasonography Evaluation of Abdominal and Peripheral Vasculopathy in Systemic Sclerosis PatientsCOMPLETED NCT07539727Clinical Value of Intestinal Ultrasound in Predicting Clinical Relapse in Crohn's Disease Patients in Deep Remission: a Multicenter Prospective Observational StudyRECRUITING

Other records listing Advanced Instrumentations, Inc. as applicant

K172931DUS-6000 Digital Ultrasonic Diagnostic Imaging System

Related Devices (Code: IYN)

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.