510(k) · Cleared
ClearedEchoNavigator R5.0
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Philips Medical Systems Nederland B.V. · QIH Automated Radiological Image Processing Software
Cleared on Mar 17, 2026 as substantially equivalent to K221270 (Philips Medical Systems Nederland B.V., 2022) after a 119-day review. Its family tree reaches back 12 generations to 1989.
- Decided
- Mar 17, 2026
- Review
- 119 days
- Class
- Class II
- Product code
- QIH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 12 generations to K890348 (1989). 67 ancestors in all, the oldest K852353 (1985). No later device cites it as a predicate yet.
- Root · 12 generations backK890348 LC, Cardiac Positioner #B5078AGeneral Electric Co. · 1989 · Recalled
- 8 generations between
- 3 generations backK121781 Echonavigator Release 1Philips Medical Systems Nederland B.V. · 2012
- 2 generations backK200713 EchoNavigatorPhilips Medical Systems Nederland B.V. · 2020
- 1 generation backK221270 EchoNavigator R4.0Philips Medical Systems Nederland B.V. · 2022
- This deviceK253614 EchoNavigator R5.0Philips Medical Systems Nederland B.V. · 2026
Show all 12 generations
- Root · 12 generations backK890348 LC, Cardiac Positioner #B5078AGeneral Electric Co. · 1989 · Recalled
- 11 generations backK993037 LCV+ Version 2Ge Medical Systems, Inc. · 2000 · Recalled
- 10 generations backK020055 Philips Integris Allura 9 with FD OptionPhilips Medical Systems · 2002 · Recalled
- 9 generations backK022899 Philips Integris Allura Flat Detector Release 1.0Philips Medical Systems North America Co. · 2002 · Recalled
- 8 generations backK031333 Philips Integris Allura Flat Detector Release 1.2Philips Medical Systems North America, Inc. · 2003 · Recalled
- 7 generations backK031836 Philips Fresco Release 1Philips Medical Systems North America Co. · 2003
- 6 generations backK062650 EP Navigator SoftwarePhilips Medical Systems · 2006
- 5 generations backK101311 EP Navigator R3Philips Medical Systems North America Co. · 2010
- 4 generations backK111245 Heartnavigator Release 1Philips Medical Systems Nederland B.V. · 2011
- 3 generations backK121781 Echonavigator Release 1Philips Medical Systems Nederland B.V. · 2012
- 2 generations backK200713 EchoNavigatorPhilips Medical Systems Nederland B.V. · 2020
- 1 generation backK221270 EchoNavigator R4.0Philips Medical Systems Nederland B.V. · 2022
- This deviceK253614 EchoNavigator R5.0Philips Medical Systems Nederland B.V. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K890348 | LC, Cardiac Positioner #B5078A | General Electric Co. | 1989 | 5 |
| −11 | K993037 | LCV+ Version 2 | Ge Medical Systems, Inc. | 2000 | 6 |
| −10 | K020055 | Philips Integris Allura 9 with FD Option | Philips Medical Systems | 2002 | 2 |
| −9 | K022899 | Philips Integris Allura Flat Detector Release 1.0 | Philips Medical Systems North America Co. | 2002 | 8 |
| −8 | K031333 | Philips Integris Allura Flat Detector Release 1.2 | Philips Medical Systems North America, Inc. | 2003 | 25 |
| −7 | K031836 | Philips Fresco Release 1 | Philips Medical Systems North America Co. | 2003 | — |
| −6 | K062650 | EP Navigator Software | Philips Medical Systems | 2006 | — |
| −5 | K101311 | EP Navigator R3 | Philips Medical Systems North America Co. | 2010 | — |
| −4 | K111245 | Heartnavigator Release 1 | Philips Medical Systems Nederland B.V. | 2011 | — |
| −3 | K121781 | Echonavigator Release 1 | Philips Medical Systems Nederland B.V. | 2012 | — |
| −2 | K200713 | EchoNavigator | Philips Medical Systems Nederland B.V. | 2020 | — |
| −1 | K221270 | EchoNavigator R4.0 | Philips Medical Systems Nederland B.V. | 2022 | — |
| 0 (this device) | K253614 | EchoNavigator R5.0 | Philips Medical Systems Nederland B.V. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1987 | 1 | 0 |
| 1991 | 1 | 0 |
| 1993 | 3 | 0 |
| 1994 | 3 | 0 |
| 1995 | 3 | 0 |
| 1996 | 2 | 0 |
| 1997 | 2 | 0 |
| 1998 | 3 | 0 |
| 1999 | 1 | 0 |
| 2000 | 4 | 0 |
| 2001 | 5 | 0 |
| 2002 | 2 | 0 |
| 2003 | 6 | 0 |
| 2004 | 9 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 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 QIH? 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 QIH device
- #1 K213998 cvi42 Auto Imaging Software Applicationscore 23.5 · 7 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 |
|---|---|---|---|
| * | K221270 | EchoNavigator R4.0Summary page 5…EchoNavigator R4.0 Device: Manufacturer: Philips Medical Systems Nederland B.V. 510(k) Clearance: K221270 (cleared on 31 May 2022) Classification Name: Medical image management and processing… | 2022 |
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 37 years and passes through 6 companies; a new generation was cleared every 2.1 years on median.
- 28 of the 67 ancestors have a recall of any class.
How does its category compare?
All QIH devicesQIH Automated Radiological Image Processing Software: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · QIH
94in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · QIH
150in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · QIH
1so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · QIH
4in 2025
MAUDE reports naming product code QIH, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 2 | — | 0 | 0 |
| 2020 | 11 | 145 | 0 | 0 |
| 2021 | 19 | 125 | 0 | 0 |
| 2022 | 25 | 134 | 0 | 0 |
| 2023 | 45 | 151 | 0 | 0 |
| 2024 | 64 | 141 | 0 | 2 |
| 2025 | 94 | 150 | 0 | 4 |
| 2026 | 78 | 130 | 1 | — |
What is it indicated for?
EchoNavigator supports the interventionalist and surgeon in treatments where both live X-ray and live Echo guidance are used. The targeted patient population consists of patients with cardiovascular diseases requiring such a treatment.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K253614 · printed Nov 6, 2026
Cite this page
510(k) Report. “K253614: EchoNavigator R5.0.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K253614
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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