Identity
- Trade Name
- Flat Panel Fixed/Portable System FDA UDI
- Generic Name
- Indirect flat panel x-ray detector FDA UDI
- Device Name
- Flat Panel Detector FDA UDI
- Model / Reference
- InnovaXion FDA UDI
- Description
- Flat Panel Detector FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00823073004016 FDA UDI
- FDA Product Code
- MQB FDA UDI
- GMDN Term
- Indirect flat panel x-ray detector FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.1680 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
No
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
Dimensions & Sizes
- Size
- Length — 480 Millimeter FDA UDIHeight — 15 Millimeter FDA UDIWeight — 3.8 Kilogram FDA UDIWidth — 491 Millimeter FDA UDI
Category: Indirect flat panel x-ray detector
Flat Panel Fixed/Portable System by Imaging Dynamics Company Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Imaging Dynamics Company Ltd
Sources (1)
- FDA UDI 73240e60-6eee-4a2d-ae06-fc13dfd4a8c8 36 fields · synced May 30, 2026