Identity
- Trade Name
- HnX-PB FDA UDI
- Generic Name
- Portable basic diagnostic x-ray system, digital FDA UDI
- Device Name
- The portable x-ray system may be used for diagnostic imaging of body extremities. - Not for mammography use - This device is not intended to replace a stationary radiographic system, which may be required for full optimization of image quality and radiation exposure for different exam types. FDA UDI
- Model / Reference
- HnX-PB FDA UDI
- Description
- The portable x-ray system may be used for diagnostic imaging of body extremities. - Not for mammography use - This device is not intended to replace a stationary radiographic system, which may be required for full optimization of image quality and radiation exposure for different exam types. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800070400166 FDA UDI
- 510(k) Number
- K251223 FDA UDI
- FDA Product Code
- IZL FDA UDI
- GMDN Term
- Portable basic diagnostic x-ray system, digital FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.1720 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Portable basic diagnostic x-ray system, digital
HnX-PB by H&abyz Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K251223 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- H&abyz Co., Ltd.
Sources (1)
- FDA UDI 3f5f45f3-b606-49e1-9274-5a6d14a22911 35 fields · synced Jun 8, 2026