Identity
- Trade Name
- THALES FDA UDI
- Generic Name
- Indirect flat panel x-ray detector FDA UDI
- Device Name
- The detector is suitable for acquiring digital images in radiography modes. It allows radiological diagnostic examinations to be performed in real time. The acquired images are saved in the system memory, displayed on a high definition monitor (HD) and eventually transmitted to a diagnostic workstation. An intermediate storage of images is performed if a wireless connection is not available. FDA UDI
- Model / Reference
- Pixium 3543EZ FDA UDI
- Description
- The detector is suitable for acquiring digital images in radiography modes. It allows radiological diagnostic examinations to be performed in real time. The acquired images are saved in the system memory, displayed on a high definition monitor (HD) and eventually transmitted to a diagnostic workstation. An intermediate storage of images is performed if a wireless connection is not available. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08054890480154 FDA UDI
- 510(k) Number
- K213081 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
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: Indirect flat panel x-ray detector
Thales by General Medical Merate Spa — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K213081 also covers:
- CLISIS SYSTEMS — GENERAL MEDICAL MERATE SPA
- CLISIS SYSTEMS — GENERAL MEDICAL MERATE SPA
- CLISIS SYSTEMS — GENERAL MEDICAL MERATE SPA
- CLISIS SYSTEMS — GENERAL MEDICAL MERATE SPA
- CLISIS SYSTEMS — GENERAL MEDICAL MERATE SPA
- Discovery RF180 — GENERAL MEDICAL MERATE SPA
- Discovery RF180 — GENERAL MEDICAL MERATE SPA
- Discovery RF180 — GENERAL MEDICAL MERATE SPA
- Discovery RF180 — GENERAL MEDICAL MERATE SPA
- THALES — GENERAL MEDICAL MERATE SPA
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
- General Medical Merate Spa
Sources (1)
- FDA UDI 5dfcacf2-1655-4f6e-b4e9-a24630a6e819 34 fields · synced Jun 8, 2026