FDA 510(k)

LOGIQ e

K-Number: K232186 · 2023-11-03

ApplicantGe Medical Systems Ultrasound and Primary Care Diagnostic,

Decision Date2023-11-03

Product CodeIYN

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

LOGIQ e is the device name listed in this FDA 510(k) record. The listed applicant is Ge Medical Systems Ultrasound and Primary Care Diagnostic,. It received FDA 510(k) clearance on 2023-11-03 under 510(k) number K232186. 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 LOGIQ e?

LOGIQ e is a medical device that received FDA 510(k) clearance on 2023-11-03. The listed applicant is Ge Medical Systems Ultrasound and Primary Care Diagnostic,. The 510(k) number is K232186.

When did LOGIQ e receive FDA 510(k) clearance?

LOGIQ e received FDA 510(k) clearance on 2023-11-03, under 510(k) number K232186.

Who is the listed applicant for LOGIQ e?

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

What is the FDA product code for LOGIQ e?

The FDA product code for LOGIQ e is IYN.

Other records listing Ge Medical Systems Ultrasound and Primary Care Diagnostic, 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.

K231989LOGIQ E10s, LOGIQ Fortis

Related Devices (Code: IYN)

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.