Identity
- Trade Name
- Interventional Fluoroscopic Mobile X-ray System FDA UDI
- Generic Name
- Mobile general-purpose fluoroscopic x-ray system, digital FDA UDI
- Device Name
- SPINEL 12HD Surgical Mobile Fluoroscopic X-ray System is intended to provide fluoroscopic and radiographic imaging of the patient during diagnostic, surgical and interventional procedures. Clinical applications may include but are not limited to digital subtraction angiography, orthopedic, neurological, abdominal, vascular, cardiac, critical care and emergency room procedures. FDA UDI
- Model / Reference
- SPINEL 12HD FDA UDI
- Description
- SPINEL 12HD Surgical Mobile Fluoroscopic X-ray System is intended to provide fluoroscopic and radiographic imaging of the patient during diagnostic, surgical and interventional procedures. Clinical applications may include but are not limited to digital subtraction angiography, orthopedic, neurological, abdominal, vascular, cardiac, critical care and emergency room procedures. FDA UDI
Identifiers
- Catalog Number
- SPINEL 12HD FDA UDI
- Primary DI / UDI-DI
- 08809246620049 FDA UDI
- 510(k) Number
- K163140 FDA UDI
- FDA Product Code
- JAA FDA UDIOXO FDA UDIOWB 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
No
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
Interventional Fluoroscopic Mobile X-ray System by Gemss Medical Systems Co., Ltd. — 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
- Gemss Medical Systems Co., Ltd.
Sources (1)
- FDA UDI 396fe8a7-9be3-4743-9b91-d54c56fe3f46 37 fields · synced Jun 8, 2026