FDA 510(k)

Lung Guidance

K-Number: K261042 · 2026-10-02

ApplicantGE Medical Systems Ultrasound & Primary Care Diagnostics, LLC

Decision Date2026-10-02

Product CodeQJU

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

Lung Guidance is the device name listed in this FDA 510(k) record. The listed applicant is GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC. It received FDA 510(k) clearance on 2026-10-02 under 510(k) number K261042. The device is classified under product code QJU. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Lung Guidance?

Lung Guidance is a medical device that received FDA 510(k) clearance on 2026-10-02. The listed applicant is GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC. The 510(k) number is K261042.

When did Lung Guidance receive FDA 510(k) clearance?

Lung Guidance received FDA 510(k) clearance on 2026-10-02, under 510(k) number K261042.

Who is the listed applicant for Lung Guidance?

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

What is the FDA product code for Lung Guidance?

The FDA product code for Lung Guidance is QJU.

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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.