Identity
- Trade Name
- DR-ID 611SE FDA UDI
- Generic Name
- Stationary basic diagnostic x-ray system, digital FDA UDI
- Device Name
- The DR-ID 600SE, DR-ID 601SE and DR-ID 602SE incorporate a GOS indirect panel. The DR-ID 611SE, DR-ID 612SE and DR-ID 613SE incorporate a CsI indirect panel. There are six types of flat panel sensors: DR-ID 601SE, DR-ID 602SE, DR-ID 611SE, DR-ID 612SE and DR-ID 613SE (wireless/wired communication mode) and DR-ID 600SE (wired communication mode). FDA UDI
- Model / Reference
- DR-ID 611 SE WIRED W E FDA UDI
- Description
- The DR-ID 600SE, DR-ID 601SE and DR-ID 602SE incorporate a GOS indirect panel. The DR-ID 611SE, DR-ID 612SE and DR-ID 613SE incorporate a CsI indirect panel. There are six types of flat panel sensors: DR-ID 601SE, DR-ID 602SE, DR-ID 611SE, DR-ID 612SE and DR-ID 613SE (wireless/wired communication mode) and DR-ID 600SE (wired communication mode). FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04547410256963 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
Yes
FDA UDI
Category: Stationary basic diagnostic x-ray system, digital
Dr-Id 611se 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 e6720bdf-21aa-4202-810c-64e3b706f110 36 fields · synced Jun 8, 2026