FDA 510(k)
FDA class 2
Substantially Equivalent
🇰🇷 South Korea
TOPA12 Portable X-ray Unit
K Number: K230581
·
Decision Aug 16, 2023
Classifications
1
FEI Numbers
77
Registration Numbers
77
Same Product Code
235
Applicant Total
2
Review Days
167
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Basic Information
- Device Name
- TOPA12 Portable X-ray Unit
- K Number
- K230581
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1720
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Neuf, Inc.
- Date Received
- March 2, 2023
- Decision Date
- August 16, 2023
- 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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Other Clearances by Neuf, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K211383 | NFLK-2501 Portable X-ray Unit | Aug 13, 2021 | Substantially Equivalent |