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Opera Swing X-Ray Remote Table Opera Swing

by General Medical Merate SpA

Opera Swing X-Ray Remote Table Opera Swing is a fluoroscopy/angiography table (FDA Class II; FDA product code KXJ, Table, Radiologic) 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 08054890480017), active as of 23 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

510(k) K140380

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number08054890480017 UDI-DI Date22 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK140380 Date26 Sep 2014DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K140380 decided 26 Sep 2014 Active
  • FDA GUDID UDI-DI 08054890480017 listed 22 Sep 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K140380
  2. Listed FDA GUDID 08054890480017

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Opera Swing
Generic name
Fluoroscopy/angiography table, powered
Model / reference
X-RAY REMOTE TABLE OPERA SWING
Primary DI / UDI-DI
08054890480017
510(k) Number
FDA product code
KXJ
GMDN term
Fluoroscopy/angiography table, powered
Device class
Class II
Regulation number
892.1980
GUDID distribution status
In Commercial Distribution
Size
Width — 65 Centimeter
Length — 240 Centimeter

Related devices

Category: Fluoroscopy/angiography table, powered

Cleared under the same submission (K140380)

Similar devices

Other devices filed under FDA product code KXJ (Table, Radiologic).

Other devices from General Medical Merate SpA

See all devices from General Medical Merate SpA →

Properties

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (12, all answered No)