Identity
- Trade Name
- Monitor cart FDA UDI
- Generic Name
- Mobile general-purpose fluoroscopic x-ray system, digital FDA UDI
- Device Name
- Monitor cart. FDA UDI
- Model / Reference
- DR-XD 3000MX FDA UDI
- Description
- Monitor cart. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04547410480689 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
Monitor cart by FUJIFILM Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Mobile general-purpose fluoroscopic x-ray system, digital.
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- 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:
- FDR CROSS — FUJIFILM Corporation
- 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
- 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 1e2135ad-c14e-428a-9cd6-24eb56167129 36 fields · synced Jun 1, 2026