510(k) · Cleared
Recalled · Class II · 2022StentBoost Live
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Philips Medical Stystems Nederland BV · OWB Interventional Fluoroscopic X-Ray System
Cleared on Jun 7, 2017 as substantially equivalent to K132305 (Philips Medical Systems Nederland B.V., 2013) after a 141-day review. Its family tree reaches back 1 generation to 2013. It has been recalled once.
- Decided
- Jun 7, 2017
- Review
- 141 days
- Class
- Class II
- Product code
- OWB
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K132305 (2013). No later device cites it as a predicate yet.
- Root · 1 generation backK132305 Stentboost Rel. 4Philips Medical Systems Nederland B.V. · 2013
- This deviceK170144 StentBoost LivePhilips Medical Stystems Nederland BV · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K132305 | Stentboost Rel. 4 | Philips Medical Systems Nederland B.V. | 2013 | — |
| 0 (this device) | K170144 | StentBoost Live | Philips Medical Stystems Nederland BV | 2017 | — |
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 |
|---|---|---|---|
| * | K132305 | Stentboost Rel. 4Summary page 4…tentBoost Rel. 4 Manufacturer: Philips Medical Systems Nederland B.V. 510(k) Clearance: K132305 (October 30, 2013) Classification Name: Image-intensified fluoroscopic x-ray system… | 2013 |
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 |
|---|---|---|---|---|
| Feb 2, 2022 | Class II | Z-0874-2022 | Under Investigation by firm | Due to a software defect, the Philips StentBoost Live R2.0 might not process X-ray images of the current run and instead show an image processed in a previous run. The image shown could be from the same patient or from a different patient. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- 1 other device also cites its predicate K132305.
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. 2017, 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?
StentBoost Live is intended to assist the physician during percutaneous coronary interventions.
StentBoost Live provides real-time enhanced visualization of stents.
StentBoost Live provides real-time enhanced visualization of stents in relation to coronary vessels.
StentBoost Live assists in the treatment of cardiovascular diseases by visualizing the placement and deployment of
coronary stents.
StentBoost Live is suitable for use with the entire adult human population.
StentBoost Live is a software medical device and does not come in contact with a human subject.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K170144 · printed Nov 5, 2026
Cite this page
510(k) Report. “K170144: StentBoost Live.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K170144
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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