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FDA 510(k)

SONOACE 9900 DIAGNOSTIC ULTRASOUND SYSTEM

K-Number: K012867 · 2001-09-12

ApplicantMedison America, Inc.
Decision Date2001-09-12
Product CodeIYN
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SONOACE 9900 DIAGNOSTIC ULTRASOUND SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Medison America, Inc.. It received FDA 510(k) clearance on 2001-09-12 under 510(k) number K012867. 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 SONOACE 9900 DIAGNOSTIC ULTRASOUND SYSTEM?

SONOACE 9900 DIAGNOSTIC ULTRASOUND SYSTEM is a medical device that received FDA 510(k) clearance on 2001-09-12. The listed applicant is Medison America, Inc.. The 510(k) number is K012867.

When did SONOACE 9900 DIAGNOSTIC ULTRASOUND SYSTEM receive FDA 510(k) clearance?

SONOACE 9900 DIAGNOSTIC ULTRASOUND SYSTEM received FDA 510(k) clearance on 2001-09-12, under 510(k) number K012867.

Who is the listed applicant for SONOACE 9900 DIAGNOSTIC ULTRASOUND SYSTEM?

The FDA 510(k) record lists Medison America, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SONOACE 9900 DIAGNOSTIC ULTRASOUND SYSTEM?

The FDA product code for SONOACE 9900 DIAGNOSTIC ULTRASOUND SYSTEM is IYN.

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Other records listing Medison America, Inc. 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.

K032329SA 9900 PLUS DIAGNOSTIC ULTRASOUND SYSTEMK031552MYCOLOR 202 DIAGNOSTIC ULTRASOUND SYSTEM AND TRANSDUCERSK013627SONOACE SA-8000 DIAGNOSTIC ULTRASOUND SYSTEMK012887SA6000II DIAGNOSTIC ULTRASOUND SYSTEMK003525VOLUSON 730 DIAGNOSTIC ULTRASOUND SYSTEMK003121MYSONO 201 DIAGNOSTIC ULTRASOUND AND TRANSDUCERS

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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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