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Image-Intensified Fluoroscopic X-Ray System, Mobile
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM, MOBILE FDA UDI
- Generic Name
- Mobile general-purpose fluoroscopic x-ray system, digital FDA UDI
- Device Name
- The SPINEL 3G is a great solution to produce radiological images of patient during medical operations. This inverter control X-ray unit visualizes the anatomical structure on screen, which is obtained by X-ray fluoroscopy and the image intensifier. This system can be applied in emergency room, operation room, cast room or etc. of hospital. FDA UDI
- Model / Reference
- SPINEL 3G FDA UDI
- Description
- The SPINEL 3G is a great solution to produce radiological images of patient during medical operations. This inverter control X-ray unit visualizes the anatomical structure on screen, which is obtained by X-ray fluoroscopy and the image intensifier. This system can be applied in emergency room, operation room, cast room or etc. of hospital. FDA UDI
Identifiers
- Catalog Number
- SPINEL 3G FDA UDI
- Primary DI / UDI-DI
- 08809246620018 FDA UDI
- 510(k) Number
- K132289 FDA UDI
- FDA Product Code
- JAA FDA UDIOXO 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
Image-Intensified Fluoroscopic X-Ray System, Mobile 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 1be62784-c49e-4523-9041-c9ad63336d91 37 fields · synced May 29, 2026