FDA 510(k)

Versana Premier; Versana Premier Lotus; LOGIQ F

K番号: K242005 · 2024-10-02

申請者GE Medical Systems Ultrasound and Primary Care Diagnostics

決定日2024-10-02

製品コードIYN

諮問委員会RA

決定Substantially Equivalent

医療機器の概要

Versana Premier; Versana Premier Lotus; LOGIQ F is the device name listed in this FDA 510(k) record. The listed applicant is GE Medical Systems Ultrasound and Primary Care Diagnostics. It received FDA 510(k) clearance on 2024-10-02 under 510(k) number K242005. The device is classified under product code IYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

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. The listed applicant is GE Medical Systems Ultrasound and Primary Care Diagnostics. The 510(k) number is K242005.

When did Versana Premier; Versana Premier Lotus; LOGIQ F receive FDA 510(k) clearance?

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

Who is the listed applicant for Versana Premier; Versana Premier Lotus; LOGIQ F?

The FDA 510(k) record lists GE Medical Systems Ultrasound and Primary Care Diagnostics as the applicant. This does not by itself establish the device manufacturer.

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.

申請者としてGE Medical Systems Ultrasound and Primary Care Diagnosticsを記載するその他の記録

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