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FDA 510(k)

CTS-7700 DIGITAL ULTRASOUND IMAGING SYSTEM

K-Number: K070982 · 2007-05-02

ApplicantShantou Institute of Ultrasonic Instuments
Decision Date2007-05-02
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

CTS-7700 DIGITAL 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 2007-05-02 under 510(k) number K070982. 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 CTS-7700 DIGITAL ULTRASOUND IMAGING SYSTEM?

CTS-7700 DIGITAL ULTRASOUND IMAGING SYSTEM is a medical device that received FDA 510(k) clearance on 2007-05-02. The listed applicant is Shantou Institute of Ultrasonic Instuments. The 510(k) number is K070982.

When did CTS-7700 DIGITAL ULTRASOUND IMAGING SYSTEM receive FDA 510(k) clearance?

CTS-7700 DIGITAL ULTRASOUND IMAGING SYSTEM received FDA 510(k) clearance on 2007-05-02, under 510(k) number K070982.

Who is the listed applicant for CTS-7700 DIGITAL 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 CTS-7700 DIGITAL ULTRASOUND IMAGING SYSTEM?

The FDA product code for CTS-7700 DIGITAL ULTRASOUND IMAGING SYSTEM is IYO.

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Other records listing Shantou Institute of Ultrasonic Instuments 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.

K113613DIGITAL COLOR DOPPLER ULTRASOUND IMAGING SYSTEMK092907DIGITAL ULTRASOUND IMAGING SYSTEM, CONVEX ARRAY TRANSDUCER, LINEAR ARRAY TRANSDUCER, CONVEX ARRAY TRANSDUCER, PHASED ARRK081110SIUI CTS-900 DIGITAL ULTRASOUND IMAGING SYSTEMK061083CTS-7700K013327CTS-415K012772CTS-485 ULTRASOUND IMAGING SYSTEM

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Related Devices (Code: IYO)

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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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