Identity
- Trade Name
- OPERA SWING FDA UDI
- Generic Name
- Fluoroscopy/angiography table, powered FDA UDI
- Device Name
- The device is a R&F remote tilting table which allows the execution of longitudinal, trasversal and oblique scanning and lateral projections without moving the patient. It is made by carbon fiber. FDA UDI
- Model / Reference
- X-RAY REMOTE TABLE OPERA SWING FDA UDI
- Description
- The device is a R&F remote tilting table which allows the execution of longitudinal, trasversal and oblique scanning and lateral projections without moving the patient. It is made by carbon fiber. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08054890480017 FDA UDI
- 510(k) Number
- K140380 FDA UDI
- FDA Product Code
- KXJ FDA UDI
- GMDN Term
- Fluoroscopy/angiography table, powered FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.1980 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
Dimensions & Sizes
- Size
- Width — 65 Centimeter FDA UDILength — 240 Centimeter FDA UDI
Category: Fluoroscopy/angiography table, powered
Opera Swing by General Medical Merate Spa — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K140380 also covers:
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
- General Medical Merate Spa
Sources (1)
- FDA UDI 7a079fb6-da3d-4f67-b4c0-aec354c5e397 35 fields · synced Jun 1, 2026