Clearance Summary
Lung Guidance received FDA 510(k) clearance under submission number K261042, sponsored by GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2026-10-02.
- Submission: K261042
- Applicant / Sponsor: GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.2100
- Decision date: 2026-10-02
Classification & Regulation
This clearance is catalogued under FDA product code QJU and 21 CFR 892.2100, within the Radiology review panel as a Class II device.