Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

GE LOGIQ I/E & VIVID E COMPACT ULTRASOUND

K-Number: K091374 · 2009-05-26

ApplicantGe Medical Systems China Co., Ltd.
Decision Date2009-05-26
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

GE LOGIQ I/E & VIVID E COMPACT ULTRASOUND is the device name listed in this FDA 510(k) record. The listed applicant is Ge Medical Systems China Co., Ltd.. It received FDA 510(k) clearance on 2009-05-26 under 510(k) number K091374. 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 LOGIQ I/E & VIVID E COMPACT ULTRASOUND?

GE LOGIQ I/E & VIVID E COMPACT ULTRASOUND is a medical device that received FDA 510(k) clearance on 2009-05-26. The listed applicant is Ge Medical Systems China Co., Ltd.. The 510(k) number is K091374.

When did GE LOGIQ I/E & VIVID E COMPACT ULTRASOUND receive FDA 510(k) clearance?

GE LOGIQ I/E & VIVID E COMPACT ULTRASOUND received FDA 510(k) clearance on 2009-05-26, under 510(k) number K091374.

Who is the listed applicant for GE LOGIQ I/E & VIVID E COMPACT ULTRASOUND?

The FDA 510(k) record lists Ge Medical Systems China Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GE LOGIQ I/E & VIVID E COMPACT ULTRASOUND?

The FDA product code for GE LOGIQ I/E & VIVID E COMPACT ULTRASOUND is IYO.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Ge Medical Systems China Co., Ltd. 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.

K171580Monitor B125, Monitor B105K130584MONITOR B40K122253PROCARE MONITOR B20K123238ACHILLESK120598PROCARE MONITOR B40K103633ACHILLES

View all 10 devices →

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.

↑