510(k) clearance
Lung Guidance
- 510(k) number
- K261042
- Applicant
- GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC
- Decision date
- Oct 2, 2026
- Date received
- Mar 31, 2026
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Product code
- QJU
- Device type
- Image Acquisition And/Or Optimization Guided By Artificial Intelligence
- Device class
- Class II
- Regulation
- 21 CFR 892.2100
- Advisory committee
- Radiology
- Statement or summary
- Summary
- Third party
- N
- Location
- Waukesha, WI, US