Opera Swing Stretcher
Opera Swing Stretcher is a radiographic stretcher (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 08054890480031), 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 | Number08054890480031 | Date22 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK140380 | Date26 Sep 2014 | StatusActive |
Official records
- AccessGUDID record 08054890480031
- FDA 510(k) database K140380
Across registries
- FDA 510(k) K140380 decided 26 Sep 2014 Active
- FDA GUDID UDI-DI 08054890480031 listed 22 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K140380
- Listed FDA GUDID 08054890480031
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Opera Swing
- Generic name
- Radiographic stretcher
- Model / reference
- STRETCHER
- Primary DI / UDI-DI
- 08054890480031
- 510(k) Number
- FDA product code
- JAA
- GMDN term
- Radiographic stretcher
- Device class
- Class II
- Regulation number
- 892.1650
- GUDID distribution status
- In Commercial Distribution
- Size
- Width — 65 CentimeterLength — 210 Centimeter
Similar devices
Other devices filed under FDA product code JAA (System, X-Ray, Fluoroscopic, Image-Intensified).
- TDA-4000/A4 by Toshiba America Medical Systems, In.C
- UNBRANDED 05-CD2720 by Advance Medical Designs, Inc.
- FLUOREX by Toshiba America Medical Systems, In.C
- MULTI CAMERA CONTROL UNIT (MCCU) by Leybold-Inficon, Inc.
- NRF SYSTEM by Philips Medical Systems (Cleveland), Inc.
- UNBRANDED ALMCFF by Advance Medical Designs, Inc.
- MODEL FP-100 by International Medical Designs, Inc.
- DIGITAL FLUROGRAPHIC IMAGING SYSTEM by Diasonics, Inc.
- VIDEO FLUOROSCOPE by Raymax Medical Corp.
- MULTIPURPOSE REMOTE CONTROL R/F SYSTEM DREX-UI80 by CANON INC.