Identity
- Trade Name
- PIXX2430 FDA UDI
- Generic Name
- Indirect flat panel x-ray detector FDA UDI
- Device Name
- PIXX2430 is a high-resolution digital X-Ray imaging device commonly referred to as a flat panel detect. X-Ray photons are converted to digital output signals. The digital signals are then read out by TFTs. The image data file is saved at the computer for display, which can be linked with PACS and printed by DICOM printer through acquisition software. It is specifically designed to deliver X-Ray imaging for medical, veterinary and industrial applications. FDA UDI
- Model / Reference
- PIXX2430 FDA UDI
- Description
- PIXX2430 is a high-resolution digital X-Ray imaging device commonly referred to as a flat panel detect. X-Ray photons are converted to digital output signals. The digital signals are then read out by TFTs. The image data file is saved at the computer for display, which can be linked with PACS and printed by DICOM printer through acquisition software. It is specifically designed to deliver X-Ray imaging for medical, veterinary and industrial applications. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08809378240184 FDA UDI
- 510(k) Number
- K190691 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
Category: Indirect flat panel x-ray detector
Pixx2430 by PIXXGEN Corporation — 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
- PIXXGEN Corporation
Sources (1)
- FDA UDI 3e22a13a-d129-43d6-8f1f-7c6967c26828 34 fields · synced May 29, 2026