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FDA 510(k)

GE VIVID E9 DIAGNOSTIC ULTRASOUND IMAGING SYSTEM

K-Number: K101149 · 2010-10-13

ApplicantGe Vingmed Ultrasound AS
Decision Date2010-10-13
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

GE VIVID E9 DIAGNOSTIC ULTRASOUND IMAGING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Ge Vingmed Ultrasound AS. It received FDA 510(k) clearance on 2010-10-13 under 510(k) number K101149. The device is classified under product code IYO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GE VIVID E9 DIAGNOSTIC ULTRASOUND IMAGING SYSTEM?

GE VIVID E9 DIAGNOSTIC ULTRASOUND IMAGING SYSTEM is a medical device that received FDA 510(k) clearance on 2010-10-13. The listed applicant is Ge Vingmed Ultrasound AS. The 510(k) number is K101149.

When did GE VIVID E9 DIAGNOSTIC ULTRASOUND IMAGING SYSTEM receive FDA 510(k) clearance?

GE VIVID E9 DIAGNOSTIC ULTRASOUND IMAGING SYSTEM received FDA 510(k) clearance on 2010-10-13, under 510(k) number K101149.

Who is the listed applicant for GE VIVID E9 DIAGNOSTIC ULTRASOUND IMAGING SYSTEM?

The FDA 510(k) record lists Ge Vingmed Ultrasound AS as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GE VIVID E9 DIAGNOSTIC ULTRASOUND IMAGING SYSTEM?

The FDA product code for GE VIVID E9 DIAGNOSTIC ULTRASOUND IMAGING SYSTEM is IYO.

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Other records listing Ge Vingmed Ultrasound AS 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.

K131685GE ECHOPACK131514GE VIVID E9 DIAGNOSTIC ULTRASOUND IMAGING SYSTEMK123894GE ECHOPACK120201GE VIVID E9 DIAGNOSTIC ULTRASOUND IMAGING SYSTEMK101324GE ECHOPAC MODEL BT10K092756GE VSCAN COMPACT DIAGNOSTIC ULTRASOUND SYSTEM

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Related Devices (Code: IYO)

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.

K260313MD-6000S Bladder ScannerMEDA Co., Ltd.K253452Accuro 3SRivanna Medical, Inc.K260190ARTHURROPCA ApSK252237EdgeFlow UW20Edgecare, Inc.K254021Accuro XVRivanna Medical, Inc.K253898QT Scanner 2000 Model AQT Imaging Holdings, Inc.

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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