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FDA 510(k)

Versana Premier; Versana Premier Lotus; LOGIQ F

K-Number: K242005 · 2024-10-02

ApplicantGE Medical Systems Ultrasound and Primary Care Diagnostics
Decision Date2024-10-02
Product CodeIYN
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Versana Premier; Versana Premier Lotus; LOGIQ F is a medical device manufactured by GE Medical Systems Ultrasound and Primary Care Diagnostics. It received FDA 510(k) clearance on 2024-10-02 under approval number K242005. 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 Versana Premier; Versana Premier Lotus; LOGIQ F?

Versana Premier; Versana Premier Lotus; LOGIQ F is a medical device that received FDA 510(k) clearance on 2024-10-02. It is manufactured by GE Medical Systems Ultrasound and Primary Care Diagnostics. The 510(k) number is K242005.

When was Versana Premier; Versana Premier Lotus; LOGIQ F approved by the FDA?

Versana Premier; Versana Premier Lotus; LOGIQ F received FDA 510(k) clearance on 2024-10-02, under approval number K242005.

What company makes Versana Premier; Versana Premier Lotus; LOGIQ F?

Versana Premier; Versana Premier Lotus; LOGIQ F is manufactured by GE Medical Systems Ultrasound and Primary Care Diagnostics.

What is the FDA product code for Versana Premier; Versana Premier Lotus; LOGIQ F?

The FDA product code for Versana Premier; Versana Premier Lotus; LOGIQ F is IYN.

Other Devices by GE Medical Systems Ultrasound and Primary Care Diagnostics

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Related Devices (Code: IYN)

K162845DC-40/DC-35/DC-45/DC-40S/DC-40 Pro Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. K162902ARIETTA Prologue Diagnostic Ultrasound system and TransducersHitachi , Ltd. K163138Clarius Ultrasound SystemClarius Mobile Health Corp. K163077LOGIQ E9, LOGIQ E9 XDClear 2.0GE Medical Systems Ultrasound and Primary Care Diagnostics K162583ALOKA LISENDO 880Hitachi , Ltd. K163020Xperius Ultrasound SystemPhilips Health Care

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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