FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Europa (Alternative: AiRTouch) portable X-ray system
K Number: K244049
·
Decision May 28, 2025
Classifications
1
FEI Numbers
74
Registration Numbers
74
Same Product Code
223
Applicant Total
1
Review Days
148
Basic Information
- Device Name
- Europa (Alternative: AiRTouch) portable X-ray system
- K Number
- K244049
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1720
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- LIVERMORETECH INC
- Date Received
- December 31, 2024
- Decision Date
- May 28, 2025
- Product Code
- IZL
- Advisory Committee
- Radiology
- Review Advisory Committee
- RA
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| IZL | System, X-Ray, Mobile | FDA class 2 | Radiology |
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