Identity
- Trade Name
- FDR CROSS FDA UDI
- Generic Name
- Mobile general-purpose fluoroscopic x-ray system, digital FDA UDI
- Device Name
- The DR-XD 3000 is a mobile C-arm system with detachable flat panel detector, which is intended for use in providing medical imaging for general populations including pediatrics. The device provides pulsed fluoroscopic imaging of patients during diagnostic, interventional and surgical procedures and digital radiographic imaging. It is intended for use in procedures such as holangiography, endoscopic, urologic, orthopedic, neurologic, critical care, peripheral vascular, emergency room procedures. This device does not support cardiac procedures and is not intended for use in performing mammography. FDA UDI
- Model / Reference
- DR-XD 3000 FDA UDI
- Description
- The DR-XD 3000 is a mobile C-arm system with detachable flat panel detector, which is intended for use in providing medical imaging for general populations including pediatrics. The device provides pulsed fluoroscopic imaging of patients during diagnostic, interventional and surgical procedures and digital radiographic imaging. It is intended for use in procedures such as holangiography, endoscopic, urologic, orthopedic, neurologic, critical care, peripheral vascular, emergency room procedures. This device does not support cardiac procedures and is not intended for use in performing mammography. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04547410467710 FDA UDI
- 510(k) Number
- K212956 FDA UDI
- FDA Product Code
- OWB FDA UDIJAA FDA UDI
- GMDN Term
- Mobile general-purpose fluoroscopic x-ray system, digital FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.1650 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: Mobile general-purpose fluoroscopic x-ray system, digital
Fdr Cross by FUJIFILM Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Mobile general-purpose fluoroscopic x-ray system, digital.
- Ziehm Vision RFD 3D — Ziehm Imaging, Inc. · Class II
- SURGIVISIO DEVICE — ECENTIAL ROBOTICS · Class II
- OEC — GE Hualun Medical Systems Co., Ltd · Class II
- Ziehm Vision FD — Ziehm Imaging, Inc. · Class II
- SYSTEM, X-RAY, FLUOROSCOPIC, IMAGE-INTENSIFIED — Gemss Medical Systems Co., Ltd. · Class II
- Zenition — Philips Medical Systems Nederland B.V. · Class II
- Genoray — GENORAY CO., LTD. · Class II
- FUJIFILM Healthcare Americas Corporation — A.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRL · Class II
Cleared under the same submission
K212956 also covers:
- Flat panel sensor holder — FUJIFILM Corporation
- Flat panel sensor holder — FUJIFILM Corporation
- Flat panel sensor holder — FUJIFILM Corporation
- Grid (10x12) — FUJIFILM Corporation
- Grid (14x17) — FUJIFILM Corporation
- Grid (17x17) — FUJIFILM Corporation
- Monitor cart — FUJIFILM Corporation
- Wired foot switch — FUJIFILM Corporation
- Wireless foot switch kit — FUJIFILM Corporation
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 bc6f8fee-fe50-46ad-8406-bf2d8e4429d5 36 fields · synced May 30, 2026