510(k) · Cleared
Recalled · Class II · 2025Veradius Unity
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Philips Medical Systems Nethrlands BV · OWB Interventional Fluoroscopic X-Ray System
Cleared on Oct 22, 2014 as substantially equivalent to K133819 (Philips Medical Systems Nederland B.V., 2014) after a 30-day review. Its family tree reaches back 4 generations to 2004. 11 later devices descend from it. It has been recalled 4 times.
- Decided
- Oct 22, 2014
- Review
- 30 days
- Class
- Class II
- Product code
- OWB
- Recalls
- 4
- Predicates
- 1
Its longest line of descent runs back 4 generations to K042646 (2004). 11 later devices descend from it, 3 citing it directly.
- Root · 4 generations backK042646 DynactSiemens Medical Systems, Inc. · 2004
- 3 generations backK061685 PulseraPhilips Medical Systems North America Co. · 2006
- 2 generations backK090590 Veradius, Model 718-130Philips Medical Systems North America Co. · 2009
- 1 generation backK133819 VeradiusPhilips Medical Systems Nederland B.V. · 2014
- This deviceK142708 Veradius UnityPhilips Medical Systems Nethrlands BV · 2014
- Descendant · cites it directly · 6 of its ownK183040 Zenition 70Philips Medical Systems Nederland B.V. · 2018 · Recalled
- Descendant · cites it directly · 3 of its ownK230871 Extron 5; Extron 7DRTECH Corporation · 2023
- Descendant · 2 generations on · 3 of its ownK212813 Zenition 70Philips Medical Systems Nederland B.V. · 2021 · Recalled
- Descendant · cites it directly · 1 of its ownK250010 Extron 3; Extron 5; Extron 7DRTECH Corporation · 2025
- Descendant · 3 generations on · 1 of its ownK232420 Zenition 30Philips Medical Systems Nederland B.V. · 2024
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K183040Zenition 70Philips Medical Systems Nederland B.V. · 2018 · cites it directly6descendants
- K230871Extron 5; Extron 7DRTECH Corporation · 2023 · cites it directly3descendants
- K212813Zenition 70Philips Medical Systems Nederland B.V. · 2021 · 2 generations on3descendants
- K250010Extron 3; Extron 5; Extron 7DRTECH Corporation · 2025 · cites it directly1descendant
- K232420Zenition 30Philips Medical Systems Nederland B.V. · 2024 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K042646 | Dynact | Siemens Medical Systems, Inc. | 2004 | — |
| −3 | K061685 | Pulsera | Philips Medical Systems North America Co. | 2006 | — |
| −2 | K090590 | Veradius, Model 718-130 | Philips Medical Systems North America Co. | 2009 | — |
| −1 | K133819 | Veradius | Philips Medical Systems Nederland B.V. | 2014 | — |
| 0 (this device) | K142708 | Veradius Unity | Philips Medical Systems Nethrlands BV | 2014 | — |
| +1 | K183040 | Zenition 70 | Philips Medical Systems Nederland B.V. | 2018 | 5 |
| +1 | K230871 | Extron 5; Extron 7 | DRTECH Corporation | 2023 | — |
| +2 | K212813 | Zenition 70 | Philips Medical Systems Nederland B.V. | 2021 | 4 |
| +1 | K250010 | Extron 3; Extron 5; Extron 7 | DRTECH Corporation | 2025 | — |
| +3 | K232420 | Zenition 30 | Philips Medical Systems Nederland B.V. | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 2 | 0 |
| 2025 | 3 | 0 |
| 2026 | 2 | 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 OWB? 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 OWB device
- #1 K251602 Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6…score 18.3 · 18 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 |
|---|---|---|---|
| * | K133819 | VeradiusSummary page 4…Veradius Manufacturer: Philips Medical Systems Nederland B.V. 510(k) Clearance: K133819 (July 10, 2014) Classification Regulation: 21 CFR, Part 892.1650 Classification N… | 2014 |
What descends from it? (11)
See all 113 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 25, 2025 | Class II | Z-1582-2025 | Labeling design | A wireless foot switch pedal may get stuck in the active position when the user releases the pedal, resulting in the emission of unintended radiation. |
| Oct 4, 2023 | Class II | Z-0230-2024 | Device Design | Philips has become aware of an issue with the Philips Integris-Allura, Allura Xper and Azurion systems that have been delivered to Puerto Rico without a warning label and the Source-to-Skin Distance Spacer (Tube-spacer) is missing. |
| Dec 2, 2021 | Class II | Z-0649-2022 | Under Investigation by firm | Firm discovered that the wireless foot switch can suddenly stop responding due to a firmware issue. If the wireless foot switch fails, there could be a delay or interruption of procedure if the hand switch is not used or if the wired foot… |
| Nov 12, 2021 | Class II | Z-0357-2022 | Device Design | Instructions for Use do not specify the maximum surface temperature of the X-ray tank (assembly housing the X-ray tube, beam filter & cooling oil) and the image intensifier/detector of the system as required an result in burns |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 10 years and passes through 4 companies; a new generation was cleared every 2.5 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K183040 (Philips Medical Systems Nederland B.V., 2018) has gone furthest, with 6 descendants of its own.
How does its category compare?
All OWB devicesOWB Interventional Fluoroscopic X-Ray System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · OWB
22in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OWB
148in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OWB
42so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OWB
14,008in 2025
MAUDE reports naming product code OWB, 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 | 3 | 52 | 0 | 1 |
| 2008 | 4 | 135 | 1 | 0 |
| 2009 | 9 | 99 | 0 | 0 |
| 2010 | 7 | 66 | 0 | 0 |
| 2011 | 6 | 79 | 0 | 1 |
| 2012 | 6 | 37 | 0 | 1 |
| 2013 | 11 | 119 | 10 | 27 |
| 2014 | 15 | 158 | 9 | 103 |
| 2015 | 11 | 66 | 35 | 2,134 |
| 2016 | 16 | 103 | 13 | 4,074 |
| 2017 | 20 | 76 | 13 | 1,604 |
| 2018 | 23 | 54 | 6 | 1,449 |
| 2019 | 9 | 174 | 7 | 1,558 |
| 2020 | 16 | 53 | 8 | 1,581 |
| 2021 | 24 | 60 | 31 | 1,981 |
| 2022 | 21 | 90 | 24 | 2,932 |
| 2023 | 12 | 152 | 22 | 7,604 |
| 2024 | 13 | 126 | 11 | 7,942 |
| 2025 | 22 | 148 | 30 | 14,008 |
| 2026 | 15 | 221 | 42 | — |
What is it indicated for?
The Veradius Unity device is intended to be used and operated by: adequately trained, qualified, and authorized health care professionals such as physicians, surgeons, cardiologists, radiologists, and radiographers, who have full understanding of the safety information and emergency procedures as well as the capabilities and functions of the device. The device is used for radiological guidance and visualization during diagnostic, interventional, and…
Read the full statement (121 words)
The Veradius Unity device is intended to be used and operated by: adequately trained, qualified, and authorized health care professionals such as physicians, surgeons, cardiologists, radiologists, and radiographers, who have full understanding of the safety information and emergency procedures as well as the capabilities and functions of the device. The device is used for radiological guidance and visualization during diagnostic, interventional, and surgical procedures on all patients except neonates (birth to one month), within the limits of the device. The device is to be used in health care facilities both inside and outside the operating room, in sterile as well as non-sterile environments, in a variety of procedures.
Applications
* Orthopedic
* Neuro
* Abdominal
* Vascular
* Thoracic
* Cardiac
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/K142708 · printed Nov 6, 2026
Cite this page
510(k) Report. “K142708: Veradius Unity.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K142708
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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