510(k) · Cleared
Recalled · Class II · 2019Apollo
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Villa Sistemi Medicali S.P.A. · KXJ Table, Radiologic
Cleared on Mar 25, 2005 after a 57-day review. The summary cites one number, which could not be confirmed as its predicate (see the table below). It has been recalled 15 times.
- Decided
- Mar 25, 2005
- Review
- 57 days
- Class
- Class II
- Product code
- KXJ
- Recalls
- 15
- Predicates
- 1
The summary cites one number, which could not be confirmed as its predicate (see the table below).
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 KXJ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K030046 | Philips Medical Systems OMNIDIAGNOST ELEVA Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 4, 2019 | Class II | Z-0765-2020 | Device Design | An amendment to the IFU and Service Manual is being issued to prescribe the replacement of the angulation chain after 8 years of service of the of the unit. After testing, it was found that due to metal fatigue under sever workload… |
| Nov 4, 2019 | Class II | Z-0766-2020 | Device Design | An amendment to the IFU and Service Manual is being issued to prescribe the replacement of the angulation chain after 8 years of service of the of the unit. After testing, it was found that due to metal fatigue under sever workload… |
| Nov 4, 2019 | Class II | Z-0764-2020 | Device Design | An amendment to the IFU and Service Manual is being issued to prescribe the replacement of the angulation chain after 8 years of service of the of the unit. After testing, it was found that due to metal fatigue under sever workload… |
| Nov 4, 2019 | Class II | Z-0763-2020 | Device Design | An amendment to the IFU and Service Manual is being issued to prescribe the replacement of the angulation chain after 8 years of service of the of the unit. After testing, it was found that due to metal fatigue under sever workload… |
| Dec 27, 2016 | Class II | Z-1430-2017 | Nonconforming Material/Component | Patient fell from the table because the footrest of the device detached from the table top while the patient was positioned on the table and table was moving from vertical position. |
| Dec 27, 2016 | Class II | Z-1429-2017 | Nonconforming Material/Component | Patient fell from the table because the footrest of the device detached from the table top while the patient was positioned on the table and table was moving from vertical position. |
| Dec 27, 2016 | Class II | Z-1427-2017 | Nonconforming Material/Component | Patient fell from the table because the footrest of the device detached from the table top while the patient was positioned on the table and table was moving from vertical position. |
| Dec 27, 2016 | Class II | Z-1428-2017 | Nonconforming Material/Component | Patient fell from the table because the footrest of the device detached from the table top while the patient was positioned on the table and table was moving from vertical position. |
| Feb 19, 2016 | Class II | Z-1063-2017 | Device Design | The analysis showed that the incident was caused by a chain of four faults: 1.) The injured person overcame a physical barrier (the tabletop support arm. height ca. 60 em) to access a prohibited area not intended as a working position. 2)… |
| Feb 19, 2016 | Class II | Z-1064-2017 | Device Design | The analysis showed that the incident was caused by a chain of four faults: 1.) The injured person overcame a physical barrier (the tabletop support arm. height ca. 60 em) to access a prohibited area not intended as a working position. 2)… |
| Feb 19, 2016 | Class II | Z-1065-2017 | Device Design | The analysis showed that the incident was caused by a chain of four faults: 1.) The injured person overcame a physical barrier (the tabletop support arm. height ca. 60 em) to access a prohibited area not intended as a working position. 2)… |
| Feb 19, 2016 | Class II | Z-1066-2017 | Device Design | The analysis showed that the incident was caused by a chain of four faults: 1.) The injured person overcame a physical barrier (the tabletop support arm. height ca. 60 em) to access a prohibited area not intended as a working position. 2)… |
| Dec 14, 2014 | Class II | Z-1079-2015 | Radiation Control for Health and Safety Act | The system does not provide the appropriate audible signal, permanent activation, and manual override, although the system is in high-level control functionality |
| Aug 2, 2013 | Class II | Z-2160-2013 | Radiation Control for Health and Safety Act | It has been discovered that the Air Kerma rate information is inconsistent in Continuous Fluoro modes 30x30 (12"x12") and 15x15 (6"x6). This could result in a deviation of the displayed values of Air Kerma Rate and Cumulated Air Kerma… |
| Dec 13, 2012 | Class II | Z-0702-2013 | Radiation Control for Health and Safety Act | Values of fluoroscopy time, Air Kerma Rate and Cumulated Air Kerma may not be displayed "at the fluoroscopist's working position" as per 21 CFR 1003.21 |
The 5 latest of 15 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
How does its category compare?
All KXJ devicesKXJ Table, Radiologic: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KXJ
FDA has decided no KXJ device since 2007.
Median 510(k) review, days · KXJ
Too few KXJ 510(k)s in any year since 2007 to give a median.
Recalls per year · KXJ
4in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KXJ
9in 2025
MAUDE reports naming product code KXJ, 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 | 0 | — | 1 | 14 |
| 2008 | 0 | — | 0 | 40 |
| 2009 | 0 | — | 0 | 6 |
| 2010 | 0 | — | 0 | 5 |
| 2011 | 0 | — | 1 | 19 |
| 2012 | 0 | — | 0 | 5 |
| 2013 | 0 | — | 0 | 5 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 2 |
| 2016 | 0 | — | 4 | 1 |
| 2017 | 0 | — | 0 | 12 |
| 2018 | 0 | — | 1 | 31 |
| 2019 | 0 | — | 4 | 4 |
| 2020 | 0 | — | 0 | 2 |
| 2021 | 0 | — | 0 | 9 |
| 2022 | 0 | — | 0 | 50 |
| 2023 | 0 | — | 0 | 12 |
| 2024 | 0 | — | 0 | 8 |
| 2025 | 0 | — | 0 | 9 |
| 2026 | 0 | — | 1 | — |
What is it indicated for?
The indication for use of the APOLLO is: radiology and fluoroscopy investigations when installed in conjunction with adequate image intensifier, image acquisition systems, X-ray generators and X-ray tubes.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K050190 · printed Nov 5, 2026
Cite this page
510(k) Report. “K050190: Apollo.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K050190
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026