510(k) · Cleared
Recalled · Class II · 2024DR 800 with MUSICA Dynamic
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Agfa Healthcare N.V. · JAA System, X-Ray, Fluoroscopic, Image-Intensified
Cleared on Apr 5, 2018 as substantially equivalent to K140380 (General Medical Merate S.P.A, 2014) after a 30-day review. Its family tree reaches back 1 generation to 2014. 9 later devices descend from it. It has been recalled 3 times.
- Decided
- Apr 5, 2018
- Review
- 30 days
- Class
- Class II
- Product code
- JAA
- Recalls
- 3
- Predicates
- 1
Its longest line of descent runs back 1 generation to K140380 (2014). 9 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK140380 Opera SwingGeneral Medical Merate S.P.A · 2014
- This deviceK180589 DR 800 with MUSICA DynamicAgfa Healthcare N.V. · 2018
- Descendant · cites it directly · 8 of its ownK183275 DR 800 with TomosynthesisAgfa N.V. · 2019 · Recalled
- Descendant · 2 generations on · 4 of its ownK193262 DR 600 with TomosynthesisAgfa N.V. · 2020
- Descendant · 3 generations on · 3 of its ownK222934 Nanox.ARCNano-X Imaging, Ltd. · 2023
- Descendant · 4 generations on · 2 of its ownK242395 Nanox.ARCNano-X Imaging, Ltd. · 2024
- Descendant · 5 generations on · 1 of its ownK250850 Nanox.ARC XNano-X Imaging, Ltd. · 2025
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K183275DR 800 with TomosynthesisAgfa N.V. · 2019 · cites it directly8descendants
- K193262DR 600 with TomosynthesisAgfa N.V. · 2020 · 2 generations on4descendants
- K222934Nanox.ARCNano-X Imaging, Ltd. · 2023 · 3 generations on3descendants
- K242395Nanox.ARCNano-X Imaging, Ltd. · 2024 · 4 generations on2descendants
- K250850Nanox.ARC XNano-X Imaging, Ltd. · 2025 · 5 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K140380 | Opera Swing | General Medical Merate S.P.A | 2014 | — |
| 0 (this device) | K180589 | DR 800 with MUSICA Dynamic | Agfa Healthcare N.V. | 2018 | — |
| +1 | K183275 | DR 800 with Tomosynthesis | Agfa N.V. | 2019 | 3 |
| +2 | K193262 | DR 600 with Tomosynthesis | Agfa N.V. | 2020 | — |
| +3 | K222934 | Nanox.ARC | Nano-X Imaging, Ltd. | 2023 | — |
| +4 | K242395 | Nanox.ARC | Nano-X Imaging, Ltd. | 2024 | — |
| +5 | K250850 | Nanox.ARC X | Nano-X Imaging, Ltd. | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 summary (predicates and 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? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K140380 | Opera SwingSummary page 4…gfa’s DR 800 with MUSICA Dynamic, which is an image-intensified fluoroscopic x-ray system. It is substantially equivalent to General Medical Merate S.P.A.’s OPERA Swing (K140380). Name of Device: OPERA Swing Common Name: System, X-Ray, Fluoroscopic, Image-Intensified Classification Name: Image-Intensified… | 2014 |
| † | K152639 | DR 600 | 2015 |
| † | K141192 | DR 400 | 2014 |
| † | K161368 | DX-D Imaging Package (DR 10s), DX-D Imaging Package (DR 14s), DX-D Imaging Package (DR… | 2016 |
| † | K103597 | DX-D 100 | 2011 |
| † | K103050 | DX-D 300 | 2010 |
| † | K112670 | DX-D 600 | 2011 |
| † | K051901 | NIO 3MP-21 | 2005 |
| † | K081963 | Agfa Computed Radiography Systems with NX2008 Workstations | 2008 |
What descends from it? (9)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K183275 | DR 800 with Tomosynthesis | 2019 | 8 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 29, 2024 | Class II | Z-2738-2024 | Device Design | Potential for the front lever chain of the DR 800 table to fail. |
| Apr 6, 2020 | Class II | Z-2202-2020 | Software design | Under specific conditions (Fluoroscopic exam, ABS=OFF, manual change of parameters) wrong calculation of the dose/minute for fluoroscopy exams can be possible |
| Jun 27, 2019 | Class II | Z-2056-2019 | Device Design | The exposed area of fluo exams possibly does not match the active area of the detector within specified limits. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- Of its descendants, K183275 (Agfa N.V., 2019) has gone furthest, with 8 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. 2018, 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 DR 800 system is indicated for performing dynamic imaging examinations (fluoroscopy and/or rapid sequence) of the following anatomies/procedures:
* Positioning fluoroscopy procedures
* Gastro-intestinal examinations
* Urogenital tract examinations
* Angiography
It is intended to replace fluoroscopic images obtained through image intensifier technology. In addition, the system is intended for project radiography of all body parts.
The DR 800 is not intended for mammography applications.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K180589 · printed Nov 5, 2026
Cite this page
510(k) Report. “K180589: DR 800 with MUSICA Dynamic.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K180589
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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