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FDA 510(k)

DUS-3000/DUS-3000PLUS DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM

K-Number: K112022 · 2011-09-22

ApplicantAdvanced Instrumentations, Inc.
Decision Date2011-09-22
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

DUS-3000/DUS-3000PLUS DIGITAL ULTRASONIC DIAGNOSTIC IMAGING 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 2011-09-22 under 510(k) number K112022. 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-3000/DUS-3000PLUS DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM?

DUS-3000/DUS-3000PLUS DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM is a medical device that received FDA 510(k) clearance on 2011-09-22. The listed applicant is Advanced Instrumentations, Inc.. The 510(k) number is K112022.

When did DUS-3000/DUS-3000PLUS DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM receive FDA 510(k) clearance?

DUS-3000/DUS-3000PLUS DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM received FDA 510(k) clearance on 2011-09-22, under 510(k) number K112022.

Who is the listed applicant for DUS-3000/DUS-3000PLUS DIGITAL ULTRASONIC DIAGNOSTIC IMAGING 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-3000/DUS-3000PLUS DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM?

The FDA product code for DUS-3000/DUS-3000PLUS DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM is IYO.

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Other records listing Advanced Instrumentations, Inc. 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.

K172931DUS-6000 Digital Ultrasonic Diagnostic Imaging SystemK172055DUS-7000 Digital Color Doppler Ultrasound SystemK132059DIAGNOSTIC ULTRASOUND SYSTEMK123048PATIENT MONITOR MODELS PM-2000A, PM-2000A+, PM-2000A PROK120075AM-6000 ANESTHESIA MACHINEK112317FM-9000 PLUS FETAL AND MATERNAL MONITOR

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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.

K260313MD-6000S Bladder ScannerMEDA Co., Ltd.K253452Accuro 3SRivanna Medical, Inc.K260190ARTHURROPCA ApSK252237EdgeFlow UW20Edgecare, Inc.K254021Accuro XVRivanna Medical, Inc.K253898QT Scanner 2000 Model AQT Imaging Holdings, Inc.

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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