FDA 510(k)
FDA class 2
Substantially Equivalent
🇰🇷 South Korea
HnX-P1, HnX-PB
K Number: K251223
·
Decision Aug 4, 2025
Classifications
1
FEI Numbers
77
Registration Numbers
77
Same Product Code
235
Applicant Total
4
Review Days
105
Basic Information
- Device Name
- HnX-P1, HnX-PB
- K Number
- K251223
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1720
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- H&abyz Co., Ltd.
- Date Received
- April 21, 2025
- Decision Date
- August 4, 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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