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FDA 510(k)

ACUSON X300 ULTRASOUND SYSTEM

K-Number: K080760 · 2008-04-25

ApplicantSiemens Medical Solutions USA, Inc., Ultrasound DI
Decision Date2008-04-25
Product CodeIYN
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ACUSON X300 ULTRASOUND SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Medical Solutions USA, Inc., Ultrasound DI. It received FDA 510(k) clearance on 2008-04-25 under 510(k) number K080760. 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 ACUSON X300 ULTRASOUND SYSTEM?

ACUSON X300 ULTRASOUND SYSTEM is a medical device that received FDA 510(k) clearance on 2008-04-25. The listed applicant is Siemens Medical Solutions USA, Inc., Ultrasound DI. The 510(k) number is K080760.

When did ACUSON X300 ULTRASOUND SYSTEM receive FDA 510(k) clearance?

ACUSON X300 ULTRASOUND SYSTEM received FDA 510(k) clearance on 2008-04-25, under 510(k) number K080760.

Who is the listed applicant for ACUSON X300 ULTRASOUND SYSTEM?

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

What is the FDA product code for ACUSON X300 ULTRASOUND SYSTEM?

The FDA product code for ACUSON X300 ULTRASOUND SYSTEM is IYN.

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Other records listing Siemens Medical Solutions USA, Inc., Ultrasound DI 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.

K163289syngo. CT Single Source Dual Energy (twin beam)K113179ACUSON SC2000 DIAGNOSTIC ULTRASOUND SYSTEMK112596ACUSON S2000 DIAGNOSTIC ULTRASOUND SYSTEMK081148SIEMENS ACUSON 2000 ULTRASOUND SYSTEM WITH ABVS TRANSDUCERK082142ACUSON S2000 DIAGNOSTIC ULTRASOUND SYSTEMK081121MODIFICATION TO ACUSON X150 ULTRASOUND SYSTEM

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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.

K262548EPIQ Inspira Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLCK263182EVO X30 Diagnostic Ultrasound System; EVO X20 Diagnostic Ultrasound System; EVO X10 Diagnostic Ultrasound System; EVO XP30 Diagnostic Ultrasound System; EVO XP20 Diagnostic Ultrasound System; EVO XP10 Diagnostic Ultrasound System; EVO XC30 Diagnostic Ultrasound System; EVO XC20 Diagnostic Ultrasound System; EVO XC10 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.K261313Vivid Explorer/Vivid Advanced/Vivid FocusGE Medical Systems Ultrasound and Primary Care DiagnosticsK254027Digital Color Doppler Ultrasound System (Marvo 95/Marvo 95 Elite/Marvo 90/Marvo 90 CV/Marvo 90 Pro/Marvo 90 Exp/Marvo 90 Elite/Marvo Expert/Marvo 85/Marvo 85 Pro/Marvo 85 Exp/Marvo 85 Elite/Marvo Senior/Marvo 75 Elite/Marvo 75i/Fenix 95/Fenix 95 Elite/Fenix 90/Fenix 90 Elite/Fenix Expert/Fenix 85/Fenix 85 Elite/Fenix Senior/Fenix 75 Elite/Fenix 75i/Endo 80/Endo 90)Sonoscape Medical Corp.K261668Venue GoGE Medical Systems Ultrasound and Primary care Diagnostics, LLCK262311Alturion Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC

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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