FDA 510(k)

DIGITAL COLOR DOPPLER ULTRASOUND IMAGING SYSTEM

K-Number: K113613 · 2012-06-15

ApplicantShantou Institute of Ultrasonic Instuments

Decision Date2012-06-15

Product CodeIYN

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

DIGITAL COLOR DOPPLER ULTRASOUND IMAGING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Shantou Institute of Ultrasonic Instuments. It received FDA 510(k) clearance on 2012-06-15 under 510(k) number K113613. 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 DIGITAL COLOR DOPPLER ULTRASOUND IMAGING SYSTEM?

DIGITAL COLOR DOPPLER ULTRASOUND IMAGING SYSTEM is a medical device that received FDA 510(k) clearance on 2012-06-15. The listed applicant is Shantou Institute of Ultrasonic Instuments. The 510(k) number is K113613.

When did DIGITAL COLOR DOPPLER ULTRASOUND IMAGING SYSTEM receive FDA 510(k) clearance?

DIGITAL COLOR DOPPLER ULTRASOUND IMAGING SYSTEM received FDA 510(k) clearance on 2012-06-15, under 510(k) number K113613.

Who is the listed applicant for DIGITAL COLOR DOPPLER ULTRASOUND IMAGING SYSTEM?

The FDA 510(k) record lists Shantou Institute of Ultrasonic Instuments as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DIGITAL COLOR DOPPLER ULTRASOUND IMAGING SYSTEM?

The FDA product code for DIGITAL COLOR DOPPLER ULTRASOUND IMAGING SYSTEM is IYN.

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Other records listing Shantou Institute of Ultrasonic Instuments as applicant

K092907DIGITAL ULTRASOUND IMAGING SYSTEM, CONVEX ARRAY TRANSDUCER, LINEAR ARRAY TRANSDUCER, CONVEX ARRAY TRANSDUCER, PHASED ARR K081110SIUI CTS-900 DIGITAL ULTRASOUND IMAGING SYSTEM K070982CTS-7700 DIGITAL ULTRASOUND IMAGING SYSTEM K061083CTS-7700 K013327CTS-415 K012772CTS-485 ULTRASOUND IMAGING SYSTEM

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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.