Identity
- Trade Name
- Portable X-ray Unit FDA UDI
- Generic Name
- Diagnostic x-ray system generator, portable FDA UDI
- Device Name
- AJEX135H is a portable X-ray unit designed for ease usage. Applying high frequency inverter type X-ray generator. - X-ray tube voltage(kV) : 50 ~ 100 kV - X-ray tube curren time product(mAs) : 0.4 ~ 105 mAs FDA UDI
- Model / Reference
- AJEX135H FDA UDI
- Description
- AJEX135H is a portable X-ray unit designed for ease usage. Applying high frequency inverter type X-ray generator. - X-ray tube voltage(kV) : 50 ~ 100 kV - X-ray tube curren time product(mAs) : 0.4 ~ 105 mAs FDA UDI
Identifiers
- Catalog Number
- AJEX135H FDA UDI
- Primary DI / UDI-DI
- 08809250370060 FDA UDI
- 510(k) Number
- K052341 FDA UDI
- FDA Product Code
- IZL FDA UDI
- GMDN Term
- Diagnostic x-ray system generator, portable 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Diagnostic x-ray system generator, portable
Portable X-ray Unit by AJEX Meditech Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K052341 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
- AJEX Meditech Ltd
Sources (1)
- FDA UDI cbd497ca-3d49-40c6-9e45-f51e865b5ba8 37 fields · synced May 30, 2026