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FDA 510(k)

SONOSCAPE SSI-1000/SSI-5000 ULTRASOUND TRANSDUCERS

K-Number: K052042 · 2005-08-09

ApplicantSonoscape Company Limited
Decision Date2005-08-09
Product CodeIYN
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SONOSCAPE SSI-1000/SSI-5000 ULTRASOUND TRANSDUCERS 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 2005-08-09 under 510(k) number K052042. 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 SONOSCAPE SSI-1000/SSI-5000 ULTRASOUND TRANSDUCERS?

SONOSCAPE SSI-1000/SSI-5000 ULTRASOUND TRANSDUCERS is a medical device that received FDA 510(k) clearance on 2005-08-09. The listed applicant is Sonoscape Company Limited. The 510(k) number is K052042.

When did SONOSCAPE SSI-1000/SSI-5000 ULTRASOUND TRANSDUCERS receive FDA 510(k) clearance?

SONOSCAPE SSI-1000/SSI-5000 ULTRASOUND TRANSDUCERS received FDA 510(k) clearance on 2005-08-09, under 510(k) number K052042.

Who is the listed applicant for SONOSCAPE SSI-1000/SSI-5000 ULTRASOUND TRANSDUCERS?

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 SONOSCAPE SSI-1000/SSI-5000 ULTRASOUND TRANSDUCERS?

The FDA product code for SONOSCAPE SSI-1000/SSI-5000 ULTRASOUND TRANSDUCERS is IYN.

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Related Devices (Code: IYN)

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.

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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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