510(k) · Cleared
Recalled · Class II · 2025Zenition 70
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Philips Medical Systems Nederland B.V. · OWB Interventional Fluoroscopic X-Ray System
Cleared on Dec 6, 2018 as substantially equivalent to K142708 (Philips Medical Systems Nethrlands BV, 2014) after a 35-day review. Its family tree reaches back 5 generations to 2004. 6 later devices descend from it. It has been recalled 5 times.
- Decided
- Dec 6, 2018
- Review
- 35 days
- Class
- Class II
- Product code
- OWB
- Recalls
- 5
- Predicates
- 1
Its longest line of descent runs back 5 generations to K042646 (2004). 6 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK042646 DynactSiemens Medical Systems, Inc. · 2004
- 4 generations backK061685 PulseraPhilips Medical Systems North America Co. · 2006
- 3 generations backK090590 Veradius, Model 718-130Philips Medical Systems North America Co. · 2009
- 2 generations backK133819 VeradiusPhilips Medical Systems Nederland B.V. · 2014
- 1 generation backK142708 Veradius UnityPhilips Medical Systems Nethrlands BV · 2014 · Recalled
- This deviceK183040 Zenition 70Philips Medical Systems Nederland B.V. · 2018
- Descendant · cites it directly · 3 of its ownK212813 Zenition 70Philips Medical Systems Nederland B.V. · 2021 · Recalled
- Descendant · 2 generations on · 1 of its ownK232420 Zenition 30Philips Medical Systems Nederland B.V. · 2024
- Descendant · cites it directly · 1 of its ownK222080 Garion Image-Intensified Fluoroscopic X-Ray System, MobileSg Healthcare Co, Ltd. · 2022
- Descendant · 3 generations on · 0 of its ownK254205 Zenition 30Philips Medical Systems Nederland B.V. · 2026
- Descendant · 2 generations on · 0 of its ownK243411 Diagnostic X-ray SystemNanjing Perlove Medical Equipment Co., Ltd. · 2025
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K212813Zenition 70Philips Medical Systems Nederland B.V. · 2021 · cites it directly3descendants
- K232420Zenition 30Philips Medical Systems Nederland B.V. · 2024 · 2 generations on1descendant
- K222080Garion Image-Intensified Fluoroscopic X-Ray System, MobileSg Healthcare Co, Ltd. · 2022 · cites it directly1descendant
- K254205Zenition 30Philips Medical Systems Nederland B.V. · 2026 · 3 generations on0descendants
- K243411Diagnostic X-ray SystemNanjing Perlove Medical Equipment Co., Ltd. · 2025 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K042646 | Dynact | Siemens Medical Systems, Inc. | 2004 | — |
| −4 | K061685 | Pulsera | Philips Medical Systems North America Co. | 2006 | — |
| −3 | K090590 | Veradius, Model 718-130 | Philips Medical Systems North America Co. | 2009 | — |
| −2 | K133819 | Veradius | Philips Medical Systems Nederland B.V. | 2014 | — |
| −1 | K142708 | Veradius Unity | Philips Medical Systems Nethrlands BV | 2014 | 4 |
| 0 (this device) | K183040 | Zenition 70 | Philips Medical Systems Nederland B.V. | 2018 | — |
| +1 | K212813 | Zenition 70 | Philips Medical Systems Nederland B.V. | 2021 | 4 |
| +2 | K232420 | Zenition 30 | Philips Medical Systems Nederland B.V. | 2024 | — |
| +1 | K222080 | Garion Image-Intensified Fluoroscopic X-Ray System, Mobile | Sg Healthcare Co, Ltd. | 2022 | — |
| +3 | K254205 | Zenition 30 | Philips Medical Systems Nederland B.V. | 2026 | — |
| +2 | K243411 | Diagnostic X-ray System | Nanjing Perlove Medical Equipment Co., Ltd. | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2024 | 2 | 0 |
| 2025 | 1 | 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 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 |
|---|---|---|---|
| * | K142708 | Veradius UnitySummary page 5…Veradius Unity Predicate Manufacturer: Philips Medical Systems Nederland B.V. Device: 510(k) Clearance: K142708 Classification Name: Image-intensified fluoroscopic x-ray system Classification… | 2014 |
What descends from it? (6)
2 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-1581-2025 | 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-0226-2024 | 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. |
| Jul 20, 2023 | Class II | Z-1583-2025 | Software design | Philips has become aware of the potential for unintended radiation exposure with Zenition 70 systems with Vascular Extension option and a Wireless Foot Switch. |
| Dec 2, 2021 | Class II | Z-0648-2022 | 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… |
| Apr 10, 2020 | Class II | Z-1933-2020 | Device Design | When strain relief is lost at the stand side of the Stand MVS Trolley Cable, over time one or more electrical contacts could break due to pulling, twisting, or dropping of the connector. If this happens, live parts may be exposed (230 V)… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 14 years and passes through 4 companies; a new generation was cleared every 2.5 years on median.
- 1 of the 5 ancestors has a recall of any class.
- Of its descendants, K212813 (Philips Medical Systems Nederland B.V., 2021) has gone furthest, with 3 descendants of its own.
- 2 other devices also cite its predicate K142708.
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. 2018, 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 Zenition 70 device is intended to be used and operated by: adequately trained, qualified and authorized health care professionals 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…
Read the full statement (112 words)
The Zenition 70 device is intended to be used and operated by: adequately trained, qualified and authorized health care professionals 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, sterile as well as non-sterile environment in a variety of procedures.
Applications:
• Orthopedic
• Neuro
• Abdominal
• Vascular
• Thoracic
• Cardiac
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K183040 · printed Nov 5, 2026
Cite this page
510(k) Report. “K183040: Zenition 70.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K183040
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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