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FDA 510(k)

SC2000 DIAGNOSTIC ULTRASOUND SYSTEM

K-Number: K102017 · 2010-09-20

ApplicantSiemens Medical Solutions USA, Inc.
Decision Date2010-09-20
Product CodeIYN
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SC2000 DIAGNOSTIC ULTRASOUND SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Medical Solutions USA, Inc.. It received FDA 510(k) clearance on 2010-09-20 under 510(k) number K102017. 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 SC2000 DIAGNOSTIC ULTRASOUND SYSTEM?

SC2000 DIAGNOSTIC ULTRASOUND SYSTEM is a medical device that received FDA 510(k) clearance on 2010-09-20. The listed applicant is Siemens Medical Solutions USA, Inc.. The 510(k) number is K102017.

When did SC2000 DIAGNOSTIC ULTRASOUND SYSTEM receive FDA 510(k) clearance?

SC2000 DIAGNOSTIC ULTRASOUND SYSTEM received FDA 510(k) clearance on 2010-09-20, under 510(k) number K102017.

Who is the listed applicant for SC2000 DIAGNOSTIC ULTRASOUND SYSTEM?

The FDA 510(k) record lists Siemens Medical Solutions USA, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SC2000 DIAGNOSTIC ULTRASOUND SYSTEM?

The FDA product code for SC2000 DIAGNOSTIC ULTRASOUND SYSTEM is IYN.

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Related Devices (Code: IYN)

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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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