# K140380: Opera Swing

- Pathway: 510(k) (Traditional)
- Applicant: General Medical Merate S.P.A
- Decided: Sep 26, 2014 after 224 days
- Product code: JAA (System, X-Ray, Fluoroscopic, Image-Intensified)
- Device class: 2
- Regulation: 21 CFR 892.1650
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
10 later devices descend from it; 1 cites it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K180589: DR 800 with MUSICA Dynamic (2018), 9 descendants of its own
- K183275: DR 800 with Tomosynthesis (2019), 8 descendants of its own
- K193262: DR 600 with Tomosynthesis (2020), 4 descendants of its own
- K222934: Nanox.ARC (2023), 3 descendants of its own
- K242395: Nanox.ARC (2024), 2 descendants of its own

## Indications for use
The Opera Swing is indicated for performing general radiography, fluoroscopy and angiography procedures/applications. The device is intended for use in: - Skeleton - Chest and lungs - Pediatrics - Emergency/traumatology - Gastroenterology - Urology and gynecology - Linear tomography - Digital angiography - Stitching

Source page: https://510kreport.com/device/K140380
Methodology: https://510kreport.com/methodology