FDA 510(k)

DIGITAL COLOR DOPPLER ULTRASOUND IMAGING SYSTEM, CONVEX ARRAY TRANSDUCER, LINEAR ARRAY

K-Number: K101008 · 2010-06-08

ApplicantShantou Institute of Ultrasonic Instruments (Siui

Decision Date2010-06-08

Product CodeITX

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

DIGITAL COLOR DOPPLER ULTRASOUND IMAGING SYSTEM, CONVEX ARRAY TRANSDUCER, LINEAR ARRAY is the device name listed in this FDA 510(k) record. The listed applicant is Shantou Institute of Ultrasonic Instruments (Siui. It received FDA 510(k) clearance on 2010-06-08 under 510(k) number K101008. The device is classified under product code ITX. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DIGITAL COLOR DOPPLER ULTRASOUND IMAGING SYSTEM, CONVEX ARRAY TRANSDUCER, LINEAR ARRAY?

DIGITAL COLOR DOPPLER ULTRASOUND IMAGING SYSTEM, CONVEX ARRAY TRANSDUCER, LINEAR ARRAY is a medical device that received FDA 510(k) clearance on 2010-06-08. The listed applicant is Shantou Institute of Ultrasonic Instruments (Siui. The 510(k) number is K101008.

When did DIGITAL COLOR DOPPLER ULTRASOUND IMAGING SYSTEM, CONVEX ARRAY TRANSDUCER, LINEAR ARRAY receive FDA 510(k) clearance?

DIGITAL COLOR DOPPLER ULTRASOUND IMAGING SYSTEM, CONVEX ARRAY TRANSDUCER, LINEAR ARRAY received FDA 510(k) clearance on 2010-06-08, under 510(k) number K101008.

Who is the listed applicant for DIGITAL COLOR DOPPLER ULTRASOUND IMAGING SYSTEM, CONVEX ARRAY TRANSDUCER, LINEAR ARRAY?

The FDA 510(k) record lists Shantou Institute of Ultrasonic Instruments (Siui 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, CONVEX ARRAY TRANSDUCER, LINEAR ARRAY?

The FDA product code for DIGITAL COLOR DOPPLER ULTRASOUND IMAGING SYSTEM, CONVEX ARRAY TRANSDUCER, LINEAR ARRAY is ITX.

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Other records listing Shantou Institute of Ultrasonic Instruments (Siui as applicant

K110841DIGITAL COLOR DOPPLER ULTRASOUND IMAGING SYSTEM, CONVEX / LINEAR / PHASED ARRAY TRANSDUCER K103144DIGITAL COLOR DOPPLER ULTRASOUND IMAGAING SYSTEM; CONVEX / LINEAR PHASED ARRAY TRANSDUCER K102023DIGITAL COLOR DOPPLER ULTRASOUND IMAGING SYSTEM, MODEL APOGEE 3500, CONVEX ARRAY TRANSDUCER, MODEL C3L60C K061488CTS-5500/CTS-6600 ULTRASONIC PULSED ECHO IMAGING SYSTEM

Related Devices (Code: ITX)

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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.