Opera Swing Opera D4000RF
Opera Swing Opera D4000RF is a medical device (FDA Class II; FDA product code JAA, System, X-Ray, Fluoroscopic, Image-Intensified) made by General Medical Merate SpA, cleared under FDA 510(k) K140380 on 26 Sep 2014 and listed in FDA GUDID since 22 Sep 2016 (UDI-DI 08054890480048), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number08054890480048 | Date22 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK140380 | Date26 Sep 2014 | StatusActive |
Official records
- AccessGUDID record 08054890480048
- FDA 510(k) database K140380
Across registries
- FDA 510(k) K140380 decided 26 Sep 2014 Active
- FDA GUDID UDI-DI 08054890480048 listed 22 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K140380
- Listed FDA GUDID 08054890480048
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Opera Swing
- Generic name
- Stationary general-purpose fluoroscopic x-ray system, digital
- Model / reference
- OPERA D4000RF
- Primary DI / UDI-DI
- 08054890480048
- 510(k) Number
- FDA product code
- JAA
- GMDN term
- Stationary general-purpose fluoroscopic x-ray system, digital
- Device class
- Class II
- Regulation number
- 892.1650
- GUDID distribution status
- In Commercial Distribution
Similar devices in this category
Other devices filed under Stationary general-purpose fluoroscopic x-ray system, digital.