510(k) · Cleared
ClearedOpera Swing
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
General Medical Merate S.P.A · JAA System, X-Ray, Fluoroscopic, Image-Intensified
Cleared on Sep 26, 2014 after a 224-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 10 later devices descend from it.
- Decided
- Sep 26, 2014
- Review
- 224 days
- Class
- Class II
- Product code
- JAA
- Recalls
- None
- Predicates
- 0
10 later devices descend from it, 1 citing it directly.
- This deviceK140380 Opera SwingGeneral Medical Merate S.P.A · 2014
- Descendant · cites it directly · 9 of its ownK180589 DR 800 with MUSICA DynamicAgfa Healthcare N.V. · 2018 · Recalled
- Descendant · 2 generations on · 8 of its ownK183275 DR 800 with TomosynthesisAgfa N.V. · 2019 · Recalled
- Descendant · 3 generations on · 4 of its ownK193262 DR 600 with TomosynthesisAgfa N.V. · 2020
- Descendant · 4 generations on · 3 of its ownK222934 Nanox.ARCNano-X Imaging, Ltd. · 2023
- Descendant · 5 generations on · 2 of its ownK242395 Nanox.ARCNano-X Imaging, Ltd. · 2024
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K180589DR 800 with MUSICA DynamicAgfa Healthcare N.V. · 2018 · cites it directly9descendants
- K183275DR 800 with TomosynthesisAgfa N.V. · 2019 · 2 generations on8descendants
- K193262DR 600 with TomosynthesisAgfa N.V. · 2020 · 3 generations on4descendants
- K222934Nanox.ARCNano-X Imaging, Ltd. · 2023 · 4 generations on3descendants
- K242395Nanox.ARCNano-X Imaging, Ltd. · 2024 · 5 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K140380 | Opera Swing | General Medical Merate S.P.A | 2014 | — |
| +1 | K180589 | DR 800 with MUSICA Dynamic | Agfa Healthcare N.V. | 2018 | 3 |
| +2 | K183275 | DR 800 with Tomosynthesis | Agfa N.V. | 2019 | 3 |
| +3 | K193262 | DR 600 with Tomosynthesis | Agfa N.V. | 2020 | — |
| +4 | K222934 | Nanox.ARC | Nano-X Imaging, Ltd. | 2023 | — |
| +5 | K242395 | Nanox.ARC | Nano-X Imaging, Ltd. | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 1 | 0 |
| 2025 | 2 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in JAA? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new JAA device
- #1 K253103 Nexus DRF Digital X-ray Imaging Systemscore 13.2 · 7 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (10)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K180589 | DR 800 with MUSICA Dynamic | 2018 | 9 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K180589 (Agfa Healthcare N.V., 2018) has gone furthest, with 9 descendants of its own.
How does its category compare?
All JAA devicesJAA System, X-Ray, Fluoroscopic, Image-Intensified: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · JAA
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JAA
89in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JAA
4in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JAA
33in 2025
MAUDE reports naming product code JAA, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 35 | 9,517 |
| 2008 | 6 | 18 | 21 | 9,484 |
| 2009 | 0 | — | 18 | 12,040 |
| 2010 | 1 | — | 6 | 5,803 |
| 2011 | 4 | 48 | 7 | 14,000 |
| 2012 | 1 | — | 2 | 11,684 |
| 2013 | 6 | 129 | 3 | 13,706 |
| 2014 | 6 | 276 | 1 | 10,265 |
| 2015 | 3 | 197 | 1 | 2,922 |
| 2016 | 2 | — | 7 | 35 |
| 2017 | 1 | — | 3 | 56 |
| 2018 | 3 | 30 | 1 | 36 |
| 2019 | 6 | 49 | 2 | 49 |
| 2020 | 4 | 39 | 2 | 39 |
| 2021 | 6 | 104 | 2 | 35 |
| 2022 | 1 | — | 5 | 34 |
| 2023 | 2 | — | 9 | 41 |
| 2024 | 3 | 89 | 2 | 25 |
| 2025 | 2 | — | 4 | 33 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
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
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K140380 · printed Nov 6, 2026
Cite this page
510(k) Report. “K140380: Opera Swing.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K140380
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026