Identity
- Trade Name
- OPERA SWING FDA UDI
- Generic Name
- Stationary general-purpose fluoroscopic x-ray system, digital FDA UDI
- Device Name
- The Opera Swing is an x-ray diagnostic system and is indicated for performing general radiography, fluoroscopy and angiography procedures/applications. FDA UDI
- Model / Reference
- X-RAY R&F REMOTE SYSTEM OPERA SWING FDA UDI
- Description
- The Opera Swing is an x-ray diagnostic system and is indicated for performing general radiography, fluoroscopy and angiography procedures/applications. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08054890480000 FDA UDI
- 510(k) Number
- K140380 FDA UDI
- FDA Product Code
- JAA FDA UDI
- GMDN Term
- Stationary 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
Dimensions & Sizes
- Size
- Weight — 1120 Kilogram FDA UDI
Category: Stationary general-purpose fluoroscopic x-ray system, digital
Opera Swing by General Medical Merate Spa — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Stationary general-purpose fluoroscopic x-ray system, digital.
- CANON INC. — CANON INC. · Class II
- FLUOROspeed — Shimadzu Corp. · Class II
- NAUTILUS — TECHNIX SPA · Class II
- SONIALVISION G4 — Shimadzu Corp. · Class II
- Duet DRF — THALES AVS FRANCE SAS · Class II
- STEPHANIX — Stephanix · Class II
- STEPHANIX — Stephanix · Class II
- AMNOTEC — AMNOTEC International Medical GmbH · Class II
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 bbb79bb7-7e27-465a-bda9-718f1eec4beb 36 fields · synced May 30, 2026