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FDA 510(k)

DUS-6000 Digital Ultrasonic Diagnostic Imaging System

K-Number: K172931 · 2017-12-01

ApplicantAdvanced Instrumentations, Inc.
Decision Date2017-12-01
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

DUS-6000 Digital Ultrasonic Diagnostic Imaging System is a medical device manufactured by Advanced Instrumentations, Inc.. It received FDA 510(k) clearance on 2017-12-01 under approval number K172931. 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 DUS-6000 Digital Ultrasonic Diagnostic Imaging System?

DUS-6000 Digital Ultrasonic Diagnostic Imaging System is a medical device that received FDA 510(k) clearance on 2017-12-01. It is manufactured by Advanced Instrumentations, Inc.. The 510(k) number is K172931.

When was DUS-6000 Digital Ultrasonic Diagnostic Imaging System approved by the FDA?

DUS-6000 Digital Ultrasonic Diagnostic Imaging System received FDA 510(k) clearance on 2017-12-01, under approval number K172931.

What company makes DUS-6000 Digital Ultrasonic Diagnostic Imaging System?

DUS-6000 Digital Ultrasonic Diagnostic Imaging System is manufactured by Advanced Instrumentations, Inc..

What is the FDA product code for DUS-6000 Digital Ultrasonic Diagnostic Imaging System?

The FDA product code for DUS-6000 Digital Ultrasonic Diagnostic Imaging System is IYO.

Related Clinical Trials

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Related PubMed Literature

PMID: 42207283 [Legal responsibility in AI-assisted radiological reporting]. Radiologie (Heidelberg, Germany) (2026) PMID: 42204020 A Minimal UDI-DICOM Mapping Profile and Validation Artifact for Medical-Device Imaging Workflows. Journal of imaging informatics in medicine (2026) PMID: 42037982 Ethical, legal, and social implications of AI-enabled digital therapeutics: A comparative analysis of risk-based regulatory frameworks in the European Union and Japan. Digital health (2026) PMID: 41887630 Capacity building for ethical use of artificial intelligence in health: protocol for a scoping review of training initiatives and gaps in Africa. BMJ open (2026)

Other Devices by Advanced Instrumentations, Inc.

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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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