K244049
- 510(k) number
- K244049
- Device name
- Europa (Alternative: AiRTouch) portable X-ray system
- Applicant
- Livermoretech, Inc. TX · US
- Product code
- IZL — System, X-Ray, Mobile
- Decision date
- 2025-05-28
- Date received
- 2024-12-31
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K244049.pdf
Official FDA record: K244049
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.