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FDA 510(k)

S8 DIAGNOSTIC ULTRASOUND SYSTEM

K-Number: K112451 · 2011-09-16

ApplicantSonoscape Company Limited
Decision Date2011-09-16
Product CodeIYN
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

S8 DIAGNOSTIC ULTRASOUND 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 2011-09-16 under 510(k) number K112451. 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 S8 DIAGNOSTIC ULTRASOUND SYSTEM?

S8 DIAGNOSTIC ULTRASOUND SYSTEM is a medical device that received FDA 510(k) clearance on 2011-09-16. The listed applicant is Sonoscape Company Limited. The 510(k) number is K112451.

When did S8 DIAGNOSTIC ULTRASOUND SYSTEM receive FDA 510(k) clearance?

S8 DIAGNOSTIC ULTRASOUND SYSTEM received FDA 510(k) clearance on 2011-09-16, under 510(k) number K112451.

Who is the listed applicant for S8 DIAGNOSTIC ULTRASOUND 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 S8 DIAGNOSTIC ULTRASOUND SYSTEM?

The FDA product code for S8 DIAGNOSTIC ULTRASOUND SYSTEM is IYN.

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Other records listing Sonoscape Company Limited 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.

K131262DIGITAL ELECTROCARDIOGRAPHSK132527DIGITAL COLOR DOPPLER ULTASOUND SYSTEMK132768S8 EXP PORTABLE DIGITAL COLOR DOPPLER ULTRASOUND SYSTEMK131213DIGITAL COLOR DOPPLER ULTRASOUND SYSTEMK130801DIGITAL COLOR DOPPLER ULTRASOUND SYSTEMK131088PORTABLE DIGITAL COLOR DOPPLER 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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