Identity
- Trade Name
- Cradle FDA UDI
- Generic Name
- Stationary basic diagnostic x-ray system, digital FDA UDI
- Device Name
- The Cradle for 24 is used for storing the flat panel sensor in a standing position. By using in combination with the CALNEO C power supply unit or the AC adapter for cradle (optional), the battery pack for the fl at panel sensor inserted into the Cradle for 24 can be charged. In addition, when the Cradle for 24 is connected to the CALNEO C power supply unit, the wireless communication setting can be switched. FDA UDI
- Model / Reference
- DR613 STAND E FDA UDI
- Description
- The Cradle for 24 is used for storing the flat panel sensor in a standing position. By using in combination with the CALNEO C power supply unit or the AC adapter for cradle (optional), the battery pack for the fl at panel sensor inserted into the Cradle for 24 can be charged. In addition, when the Cradle for 24 is connected to the CALNEO C power supply unit, the wireless communication setting can be switched. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04547410235920 FDA UDI
- FDA Product Code
- MQB FDA UDI
- GMDN Term
- Stationary basic diagnostic x-ray system, digital 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
No
FDA UDI
Category: Stationary basic diagnostic x-ray system, digital
Cradle by FUJIFILM 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
- FUJIFILM Corporation
Sources (1)
- FDA UDI df974155-1a6d-4848-8ae5-0dbd23419012 35 fields · synced Jun 1, 2026