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FDA 510(k)

MYLAB15/20 3D/4D ULTRASOUND IMAGING SYSTEM

K-Number: K053154 · 2005-12-16

ApplicantPie Medical
Decision Date2005-12-16
Product CodeIYN
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MYLAB15/20 3D/4D ULTRASOUND IMAGING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Pie Medical. It received FDA 510(k) clearance on 2005-12-16 under 510(k) number K053154. 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 MYLAB15/20 3D/4D ULTRASOUND IMAGING SYSTEM?

MYLAB15/20 3D/4D ULTRASOUND IMAGING SYSTEM is a medical device that received FDA 510(k) clearance on 2005-12-16. The listed applicant is Pie Medical. The 510(k) number is K053154.

When did MYLAB15/20 3D/4D ULTRASOUND IMAGING SYSTEM receive FDA 510(k) clearance?

MYLAB15/20 3D/4D ULTRASOUND IMAGING SYSTEM received FDA 510(k) clearance on 2005-12-16, under 510(k) number K053154.

Who is the listed applicant for MYLAB15/20 3D/4D ULTRASOUND IMAGING SYSTEM?

The FDA 510(k) record lists Pie Medical as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MYLAB15/20 3D/4D ULTRASOUND IMAGING SYSTEM?

The FDA product code for MYLAB15/20 3D/4D ULTRASOUND IMAGING SYSTEM is IYN.

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Other records listing Pie Medical 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.

K061961ART LAB SOFTWAREK043588MYLAB 15 / MYLAB 20, MODEL 2700K043360IMT.LABK041675PICUS, PARUS, FALCO AND AQUILA ULTRASOUND SYSTEMSK033604TRINGA ULTRASOUND IMAGING SYSTEM, MODEL 50LK023512PICUS ULTRASOUND IMAGING SYSTEMS

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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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