Identity
- Trade Name
- i-Dixel FDA UDI
- Generic Name
- Basic diagnostic x-ray system application software FDA UDI
- Model / Reference
- i-Dixel FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04548213025299 FDA UDI
- 510(k) Number
- K073704 FDA UDI
- FDA Product Code
- LLZ FDA UDI
- GMDN Term
- Basic diagnostic x-ray system application software FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.2050 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
No
FDA UDI
Category: Basic diagnostic x-ray system application software
i-Dixel by J.morita Mfg.corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K073704 also covers:
- i-Dixel — J.MORITA MFG.CORP.
- i-Dixel — J.MORITA MFG.CORP.
- i-Dixel — J.MORITA MFG.CORP.
- i-Dixel — J.MORITA MFG.CORP.
- i-Dixel — J.MORITA MFG.CORP.
- i-Dixel — J.MORITA MFG.CORP.
- i-Dixel — J.MORITA MFG.CORP.
- i-Dixel — J.MORITA MFG.CORP.
- i-Dixel — J.MORITA MFG.CORP.
- i-Dixel — J.MORITA MFG.CORP.
- i-Dixel — J.MORITA MFG.CORP.
- i-Dixel — J.MORITA MFG.CORP.
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
- J.morita Mfg.corp.
Sources (1)
- FDA UDI 817776e0-6bee-40df-a634-2d88c6ec3887 34 fields · synced May 31, 2026