FDA 510(k)
FDA class 2
Substantially Equivalent
🇧🇪 Belgium
The AIO Solution
K Number: K191158
·
Decision Aug 6, 2019
Classifications
1
FEI Numbers
114
Registration Numbers
114
Same Product Code
733
Applicant Total
9
Review Days
97
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Basic Information
- Device Name
- The AIO Solution
- K Number
- K191158
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.5050
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Orfit Industries NV
- Date Received
- May 1, 2019
- Decision Date
- August 6, 2019
- Product Code
- IYE
- 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 |
|---|---|---|---|
| IYE | Accelerator, Linear, Medical | FDA class 2 | Radiology |
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