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FDA 510(k)

Versana Premier; Versana Premier Lotus; LOGIQ F

K-Number: K242005 · 2024-10-02

Decision Date2024-10-02
Product CodeIYN
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

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.

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. 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.

Other records listing GE Medical Systems Ultrasound and Primary Care Diagnostics 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.

View all 64 devices →

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.

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.