510(k) · Cleared
ClearedVeradius, Model 718-130
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Philips Medical Systems North America Co. · OWB Interventional Fluoroscopic X-Ray System
Cleared on Mar 16, 2009 as substantially equivalent to K061685 (Philips Medical Systems North America Co., 2006) after a 12-day review. Its family tree reaches back 2 generations to 2004. 14 later devices descend from it.
- Decided
- Mar 16, 2009
- Review
- 12 days
- Class
- Class II
- Product code
- OWB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K042646 (2004). 14 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK042646 DynactSiemens Medical Systems, Inc. · 2004
- 1 generation backK061685 PulseraPhilips Medical Systems North America Co. · 2006
- This deviceK090590 Veradius, Model 718-130Philips Medical Systems North America Co. · 2009
- Descendant · cites it directly · 12 of its ownK133819 VeradiusPhilips Medical Systems Nederland B.V. · 2014
- Descendant · 2 generations on · 11 of its ownK142708 Veradius UnityPhilips Medical Systems Nethrlands BV · 2014 · Recalled
- Descendant · 3 generations on · 6 of its ownK183040 Zenition 70Philips Medical Systems Nederland B.V. · 2018 · Recalled
- Descendant · 3 generations on · 3 of its ownK230871 Extron 5; Extron 7DRTECH Corporation · 2023
- Descendant · 4 generations on · 3 of its ownK212813 Zenition 70Philips Medical Systems Nederland B.V. · 2021 · Recalled
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K133819VeradiusPhilips Medical Systems Nederland B.V. · 2014 · cites it directly12descendants
- K142708Veradius UnityPhilips Medical Systems Nethrlands BV · 2014 · 2 generations on11descendants
- K183040Zenition 70Philips Medical Systems Nederland B.V. · 2018 · 3 generations on6descendants
- K230871Extron 5; Extron 7DRTECH Corporation · 2023 · 3 generations on3descendants
- K212813Zenition 70Philips Medical Systems Nederland B.V. · 2021 · 4 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K042646 | Dynact | Siemens Medical Systems, Inc. | 2004 | — |
| −1 | K061685 | Pulsera | Philips Medical Systems North America Co. | 2006 | — |
| 0 (this device) | K090590 | Veradius, Model 718-130 | Philips Medical Systems North America Co. | 2009 | — |
| +1 | K133819 | Veradius | Philips Medical Systems Nederland B.V. | 2014 | — |
| +2 | K142708 | Veradius Unity | Philips Medical Systems Nethrlands BV | 2014 | 4 |
| +3 | K183040 | Zenition 70 | Philips Medical Systems Nederland B.V. | 2018 | 5 |
| +3 | K230871 | Extron 5; Extron 7 | DRTECH Corporation | 2023 | — |
| +4 | K212813 | Zenition 70 | Philips Medical Systems Nederland B.V. | 2021 | 4 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2014 | 2 | 0 |
| 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 |
|---|---|---|---|
| * | K061685 | PulseraSummary page 1…y, mobile and Solid State X-Ray Imager (Flal Panel/Digital imager} Radiology devices Class Il 21CFR 892.1720 Class i (IZL) and 21 CFR 892.1650 Class Il (MQB} Pulsera K061685 3D-RX Option for BV Pulsera, Release 2.2 Philips Medical Systems Nederland B.V. MAR 1 6 2009 510{k) Premarket N… | 2006 |
What descends from it? (14)
See all 142 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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 5 years and passes through 2 companies; a new generation was cleared every 2.5 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K133819 (Philips Medical Systems Nederland B.V., 2014) has gone furthest, with 12 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. 2009, 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 device is intended to be used and operated by: adequately trained, qualified and authorized health care professionals such as physicians, surgeons, cardiologist, 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…
Read the full statement (109 words)
The Veradius device is intended to be used and operated by: adequately trained, qualified and authorized health care professionals such as physicians, surgeons, cardiologist, 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 babies, within the limits of the device. The device Is to be used in health care facilities both inside and outside the aperating rcom, sterile as well as non-sterile environment 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/K090590 · printed Nov 6, 2026
Cite this page
510(k) Report. “K090590: Veradius, Model 718-130.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K090590
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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