510(k) · Cleared
ClearedEP Navigator Software
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Philips Medical Systems · LLZ System, Image Processing, Radiological
Cleared on Sep 21, 2006 as substantially equivalent to K042293 (Philips Medical Systems (Cleveland), Inc., 2004) and 5 other predicates after a 14-day review. Its family tree reaches back 6 generations to 1989. 49 later devices descend from it.
- Decided
- Sep 21, 2006
- Review
- 14 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 6 generations to K890348 (1989). 36 ancestors in all. 49 later devices descend from it, 2 citing it directly.
- Root · 6 generations backK890348 LC, Cardiac Positioner #B5078AGeneral Electric Co. · 1989 · Recalled
- 5 generations backK993037 LCV+ Version 2Ge Medical Systems, Inc. · 2000 · Recalled
- 4 generations backK020055 Philips Integris Allura 9 with FD OptionPhilips Medical Systems · 2002 · Recalled
- 3 generations backK022899 Philips Integris Allura Flat Detector Release 1.0Philips Medical Systems North America Co. · 2002 · Recalled
- 2 generations backK031333 Philips Integris Allura Flat Detector Release 1.2Philips Medical Systems North America, Inc. · 2003 · Recalled
- 1 generation backK031836 Philips Fresco Release 1Philips Medical Systems North America Co. · 2003
- This deviceK062650 EP Navigator SoftwarePhilips Medical Systems · 2006
- Descendant · cites it directly · 41 of its ownK101311 EP Navigator R3Philips Medical Systems North America Co. · 2010
- Descendant · 2 generations on · 39 of its ownK111245 Heartnavigator Release 1Philips Medical Systems Nederland B.V. · 2011
- Descendant · 3 generations on · 32 of its ownK121781 Echonavigator Release 1Philips Medical Systems Nederland B.V. · 2012
- Descendant · 4 generations on · 28 of its ownK172607 Philips EPIQ 5 Diagnostic Ultrasound System, EPIQ 7 Diagnostic…Philips Health Care · 2017 · Recalled
- Descendant · 5 generations on · 27 of its ownK181485 EPIQ , EPIQ 5, EPIQ 7, Affiniti 30, Affiniti 50 and Affiniti 70…Philips Ultrasound, Inc. · 2018 · Recalled
Showing 5 of 49 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 49 · See all- K101311EP Navigator R3Philips Medical Systems North America Co. · 2010 · cites it directly41descendants
- K111245Heartnavigator Release 1Philips Medical Systems Nederland B.V. · 2011 · 2 generations on39descendants
- K121781Echonavigator Release 1Philips Medical Systems Nederland B.V. · 2012 · 3 generations on32descendants
- K172607Philips EPIQ 5 Diagnostic Ultrasound System, EPIQ 7 Diagnostic Ultrasound System…Philips Health Care · 2017 · 4 generations on28descendants
- K181485EPIQ , EPIQ 5, EPIQ 7, Affiniti 30, Affiniti 50 and Affiniti 70 Diagnostic Ultrasound…Philips Ultrasound, Inc. · 2018 · 5 generations on27descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K890348 | LC, Cardiac Positioner #B5078A | General Electric Co. | 1989 | 5 |
| −5 | K993037 | LCV+ Version 2 | Ge Medical Systems, Inc. | 2000 | 6 |
| −4 | K020055 | Philips Integris Allura 9 with FD Option | Philips Medical Systems | 2002 | 2 |
| −3 | K022899 | Philips Integris Allura Flat Detector Release 1.0 | Philips Medical Systems North America Co. | 2002 | 8 |
| −2 | K031333 | Philips Integris Allura Flat Detector Release 1.2 | Philips Medical Systems North America, Inc. | 2003 | 25 |
| −1 | K031836 | Philips Fresco Release 1 | Philips Medical Systems North America Co. | 2003 | — |
| 0 (this device) | K062650 | EP Navigator Software | Philips Medical Systems | 2006 | — |
| +1 | K101311 | EP Navigator R3 | Philips Medical Systems North America Co. | 2010 | — |
| +2 | K111245 | Heartnavigator Release 1 | Philips Medical Systems Nederland B.V. | 2011 | — |
| +3 | K121781 | Echonavigator Release 1 | Philips Medical Systems Nederland B.V. | 2012 | — |
| +4 | K172607 | Philips EPIQ 5 Diagnostic Ultrasound System, EPIQ 7 Diagnostic Ultrasound… | Philips Health Care | 2017 | 31 |
| +5 | K181485 | EPIQ , EPIQ 5, EPIQ 7, Affiniti 30, Affiniti 50 and Affiniti 70 Diagnostic… | Philips Ultrasound, Inc. | 2018 | 24 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 2 | 0 |
| 1994 | 2 | 0 |
| 1995 | 2 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 3 | 0 |
| 1999 | 1 | 0 |
| 2000 | 3 | 0 |
| 2001 | 4 | 0 |
| 2003 | 4 | 0 |
| 2004 | 6 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 4 | 0 |
| 2017 | 2 | 0 |
| 2018 | 4 | 0 |
| 2020 | 4 | 0 |
| 2021 | 2 | 0 |
| 2022 | 5 | 0 |
| 2023 | 3 | 0 |
| 2024 | 5 | 0 |
| 2025 | 9 | 0 |
| 2026 | 7 | 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 LLZ? 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 LLZ device
- #1 K230955 syngo Application Softwarescore 21.5 · 11 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (6)
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 |
|---|---|---|---|
| * | K042293 | Brilliance CT, Private Practice CV Configuration, CT ScannerSummary page 1…Allura 3D-CA, Integris 3D-RA, Stentboost, Xper CT Manufacturer: ......................... Philips (for all predicate devices) 510(k) numbers: ...................... K042293, K041955, K042334, K040254, K031836, K060749 Annex A… | 2004 |
| * | K041955 | Gemini Pet/CT Imaging SystemSummary page 1…ra 3D-CA, Integris 3D-RA, Stentboost, Xper CT Manufacturer: ......................... Philips (for all predicate devices) 510(k) numbers: ...................... K042293, K041955, K042334, K040254, K031836, K060749 Annex A… | 2004 |
| * | K042334 | Allura 3D-CA, Release 1Summary page 1…Integris 3D-RA, Stentboost, Xper CT Manufacturer: ......................... Philips (for all predicate devices) 510(k) numbers: ...................... K042293, K041955, K042334, K040254, K031836, K060749 Annex A… | 2004 |
| * | K040254 | Integris 3D-RA, Release 4.2Summary page 1…3D-RA, Stentboost, Xper CT Manufacturer: ......................... Philips (for all predicate devices) 510(k) numbers: ...................... K042293, K041955, K042334, K040254, K031836, K060749 Annex A… | 2004 |
| * | K031836 | Philips Fresco Release 1Summary page 1…tentboost, Xper CT Manufacturer: ......................... Philips (for all predicate devices) 510(k) numbers: ...................... K042293, K041955, K042334, K040254, K031836, K060749 Annex A… | 2003 |
| * | K060749 | XperctSummary page 1…........ Philips (for all predicate devices) 510(k) numbers: ...................... K042293, K041955, K042334, K040254, K031836, K060749 Annex A Page 1 of 2 Phi… | 2006 |
What descends from it? (49)
See all 492 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 17 years and passes through 5 companies; a new generation was cleared every 2.1 years on median.
- 19 of the 36 ancestors have a recall of any class.
- Of its descendants, K101311 (Philips Medical Systems North America Co., 2010) has gone furthest, with 41 descendants of its own.
- 5 other devices also cite its predicate K042293.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LLZ
58in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LLZ
173in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LLZ
11in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LLZ
116in 2025
MAUDE reports naming product code LLZ, 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 | 76 | 36 | 20 | 152 |
| 2008 | 94 | 52 | 32 | 154 |
| 2009 | 70 | 62 | 21 | 145 |
| 2010 | 51 | 98 | 17 | 145 |
| 2011 | 106 | 79 | 30 | 454 |
| 2012 | 82 | 87 | 12 | 266 |
| 2013 | 95 | 84 | 64 | 1,130 |
| 2014 | 78 | 89 | 6 | 15,631 |
| 2015 | 64 | 90 | 16 | 211 |
| 2016 | 82 | 90 | 12 | 290 |
| 2017 | 78 | 107 | 5 | 104 |
| 2018 | 104 | 105 | 7 | 72 |
| 2019 | 74 | 107 | 2 | 88 |
| 2020 | 81 | 115 | 6 | 82 |
| 2021 | 83 | 116 | 3 | 70 |
| 2022 | 65 | 137 | 4 | 28 |
| 2023 | 87 | 157 | 8 | 26 |
| 2024 | 62 | 131 | 6 | 42 |
| 2025 | 58 | 173 | 11 | 116 |
| 2026 | 45 | 110 | 14 | — |
What is it indicated for?
EP-Navigator is intended to enable users to segment previously acquired 3D CT datasets and overlay and register these 3D segmented data sets with live fluoro X-ray images of the same anatomy in order to support catheter/device navigation during specified procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K062650 · printed Nov 6, 2026
Cite this page
510(k) Report. “K062650: EP Navigator Software.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K062650
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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