510(k) · Cleared
ClearedCT TrueView
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 Aug 10, 2016 as substantially equivalent to K042334 (Philips Medical Systems North America Co., 2004) after a 202-day review. Its family tree reaches back 4 generations to 1998.
- Decided
- Aug 10, 2016
- Review
- 202 days
- Class
- Class II
- Product code
- OWB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K974367 (1998). No later device cites it as a predicate yet.
- Root · 4 generations backK974367 Advantx LCN, Advantx LCLPGE Medical Systems · 1998 · Recalled
- 3 generations backK983877 Philips Integris 3D RA OptionPhilips Medical Systems North America, Inc. · 1998
- 2 generations backK040254 Integris 3D-RA, Release 4.2Philips Medical Systems North America Co. · 2004
- 1 generation backK042334 Allura 3D-CA, Release 1Philips Medical Systems North America Co. · 2004
- This deviceK160147 CT TrueViewPhilips Medical Systems Nederland B.V. · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K974367 | Advantx LCN, Advantx LCLP | GE Medical Systems | 1998 | 7 |
| −3 | K983877 | Philips Integris 3D RA Option | Philips Medical Systems North America, Inc. | 1998 | — |
| −2 | K040254 | Integris 3D-RA, Release 4.2 | Philips Medical Systems North America Co. | 2004 | — |
| −1 | K042334 | Allura 3D-CA, Release 1 | Philips Medical Systems North America Co. | 2004 | — |
| 0 (this device) | K160147 | CT TrueView | Philips Medical Systems Nederland B.V. | 2016 | — |
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.
What descends from it?
No later submission names this one as a predicate yet.
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 18 years and passes through 4 companies; a new generation was cleared every 5.2 years on median.
- 1 of the 4 ancestors has a recall of any class.
- 2 other devices also cite its predicate K042334.
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. 2016, 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?
CT TrueView assists physicians during cardio-vascular interventions when analyzing 2D images by segmenting a previously acquired 3D CT to create a 3D model of the coronary vessel tree.
CT TrueView supports the physician navigating a catheter or guide wire through the coronary arteries by providing a composite image that combines a 2D X-ray exposure image with a CT based 3D visualization of the heart and/or coronaries.
CT TrueView is suitable for use with the adult human population.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K160147 · printed Nov 6, 2026
Cite this page
510(k) Report. “K160147: CT TrueView.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K160147
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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