Lung Guidance— 510(k) K261042
Substantially EquivalentGE Medical Systems Ultrasound & Primary Care Diagnostics, LLC
FDA 510(k) clearance K261042 for Lung Guidance, Substantially Equivalent on 2026-10-02. Applicant: GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC. Device class: 2.
Summary
Lung Guidance from GE Medical Systems Ultrasound & Primary Care Diagnostics is filed under QJU, image acquisition and/or optimization guided by artificial intelligence. The record doesn't name the imaging systems it runs on, though the applicant is GE's ultrasound business.
Class II, 21 CFR 892.2100. The Radiology panel reviewed it as a Traditional 510(k).
GE filed from Waukesha, Wisconsin. Review took 185 days (March 31 to October 2, 2026).
Clearance details
- Applicant
- GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC
- Product code
- Product code QJU
- Device class
- Class 2
- Regulation
- 21 CFR 892.2100
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Waukesha, WI, US
Recent devices under product code QJU
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