OEC Elite MiniView
FDA 510(k)FDA UDIEUDAMEDClass II (US FDA 510(k))
Identity
- Trade Name
- OEC Elite MiniView EUDAMEDOEC FDA UDI
- Generic Name
- Mobile general-purpose fluoroscopic x-ray system, digital FDA UDI
- Device Name
- MEDICAL DEVICE, UDI LABEL PLACEMENT, MiniView FDA UDI
- Model / Reference
- OEC Elite MiniView EUDAMED5730328 EUDAMEDElite MiniView FDA UDI
- Description
- MEDICAL DEVICE, UDI LABEL PLACEMENT, MiniView FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00195278502582 EUDAMEDFDA UDI
- Basic UDI-DI
- 8406821BUG00405HA EUDAMED
- FDA Product Code
- OXO FDA 510(k)FDA UDIJAA FDA UDI
- EMDN Code
- Z11039017 MOBILE RADIOSCOPIC UNITS EUDAMED
- GMDN Term
- Mobile general-purpose fluoroscopic x-ray system, digital FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA 510(k)FDA UDI
- Legislation / Framework
- 21 CFR Part 892.1650 FDA 510(k)
- Regulation Number
- 892.1650 FDA 510(k)FDA UDI
- Market of Registration
- France EUDAMED
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
No
Manufacturing Date
Yes
The OEC Elite MiniView is a mobile image-intensified fluoroscopic X-ray system designed for real-time radiographic imaging. It employs an image intensifier to amplify X-ray signals, enabling high-quality visualization of internal structures during procedures such as fluoroscopy, angiography, and interventional radiology.
This system is intended for use in clinical settings such as operating rooms, catheterization labs, and radiology departments. Supplied as a reusable device, it requires proper sterilization and maintenance per manufacturer guidelines. The system is classified as Class II under FDA regulations and has received FDA 510(k) clearance and MDR authorization. Multiple model variants are available, as indicated by the listed registration numbers.
Frequently asked questions
What clinical environments is the OEC Elite MiniView designed for and how does it support procedures in those settings?
The OEC Elite MiniView is specifically designed for mobile radiographic imaging in clinical settings like operating rooms, catheterization labs, and radiology departments. Its image-intensified fluoroscopic X-ray system provides real-time visualization of internal structures, making it ideal for procedures such as fluoroscopy, angiography, and interventional radiology where precise imaging is critical.
Is the OEC Elite MiniView a single-use or reusable device, and what maintenance is required?
The OEC Elite MiniView is a reusable device, meaning it is intended for repeated use across multiple procedures. Since it is reusable, it requires proper sterilization and maintenance following the manufacturer’s guidelines to ensure safety, performance, and compliance with regulatory standards.
How many model variants of the OEC Elite MiniView are available, and how can I identify the specific variant I need?
Multiple model variants of the OEC Elite MiniView are available, as indicated by the registration numbers listed in the regulatory records (e.g., 3013099020, 3027339477, etc.). These variants may differ in technical specifications or features, so verifying the exact registration number or consulting the manufacturer’s documentation will help identify the correct variant for your needs.
What regulatory pathways has the OEC Elite MiniView undergone, and what does this mean for its use in clinical settings?
The OEC Elite MiniView has received FDA 510(k) clearance and MDR (Medical Device Regulation) authorization, confirming its compliance with U.S. and European regulatory standards. This means the device has been evaluated for safety and effectiveness, allowing its use in clinical settings where fluoroscopic imaging is required, provided it is used as intended and maintained according to manufacturer instructions.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K171800 | Class II | Active |
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Manufacturer
- Manufacturer
- GE Hualun Medical Systems Co., Ltd
- FDA Applicant
- Ge Hualun Medical Systems Co. , Ltd.
Sources (3)
- FDA 510(k) K171800 24 fields · synced Sep 18, 2026
- FDA UDI c977c685-e912-48d5-8619-37966e850042 35 fields · synced May 30, 2026
- EUDAMED e2a9a946-892f-48d2-8929-f32126438c61 61 fields · synced Jul 20, 2026