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FDA 510(k)

SSI-600/SSI-800 DIAGNOSTIC ULTRASOUND IMAGING SYSTEM

K-Number: K041455 · 2004-06-10

ApplicantSonoscape Company Limited
Decision Date2004-06-10
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SSI-600/SSI-800 DIAGNOSTIC ULTRASOUND IMAGING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Sonoscape Company Limited. It received FDA 510(k) clearance on 2004-06-10 under 510(k) number K041455. 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 SSI-600/SSI-800 DIAGNOSTIC ULTRASOUND IMAGING SYSTEM?

SSI-600/SSI-800 DIAGNOSTIC ULTRASOUND IMAGING SYSTEM is a medical device that received FDA 510(k) clearance on 2004-06-10. The listed applicant is Sonoscape Company Limited. The 510(k) number is K041455.

When did SSI-600/SSI-800 DIAGNOSTIC ULTRASOUND IMAGING SYSTEM receive FDA 510(k) clearance?

SSI-600/SSI-800 DIAGNOSTIC ULTRASOUND IMAGING SYSTEM received FDA 510(k) clearance on 2004-06-10, under 510(k) number K041455.

Who is the listed applicant for SSI-600/SSI-800 DIAGNOSTIC ULTRASOUND IMAGING SYSTEM?

The FDA 510(k) record lists Sonoscape Company Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SSI-600/SSI-800 DIAGNOSTIC ULTRASOUND IMAGING SYSTEM?

The FDA product code for SSI-600/SSI-800 DIAGNOSTIC ULTRASOUND IMAGING SYSTEM is 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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