510(k) · Cleared
ClearedEP Navigator R3
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Philips Medical Systems North America Co. · LLZ System, Image Processing, Radiological
Cleared on Sep 30, 2010 as substantially equivalent to K062650 (Philips Medical Systems, 2006) and 4 other predicates after a 142-day review. Its family tree reaches back 7 generations to 1989. 41 later devices descend from it.
- Decided
- Sep 30, 2010
- Review
- 142 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 7 generations to K890348 (1989). 50 ancestors in all, the oldest K852353 (1985). 41 later devices descend from it, 3 citing it directly.
- Root · 7 generations backK890348 LC, Cardiac Positioner #B5078AGeneral Electric Co. · 1989 · Recalled
- 6 generations backK993037 LCV+ Version 2Ge Medical Systems, Inc. · 2000 · Recalled
- 5 generations backK020055 Philips Integris Allura 9 with FD OptionPhilips Medical Systems · 2002 · Recalled
- 4 generations backK022899 Philips Integris Allura Flat Detector Release 1.0Philips Medical Systems North America Co. · 2002 · Recalled
- 3 generations backK031333 Philips Integris Allura Flat Detector Release 1.2Philips Medical Systems North America, Inc. · 2003 · Recalled
- 2 generations backK031836 Philips Fresco Release 1Philips Medical Systems North America Co. · 2003
- 1 generation backK062650 EP Navigator SoftwarePhilips Medical Systems · 2006
- This deviceK101311 EP Navigator R3Philips Medical Systems North America Co. · 2010
- Descendant · cites it directly · 39 of its ownK111245 Heartnavigator Release 1Philips Medical Systems Nederland B.V. · 2011
- Descendant · 2 generations on · 32 of its ownK121781 Echonavigator Release 1Philips Medical Systems Nederland B.V. · 2012
- Descendant · 3 generations on · 28 of its ownK172607 Philips EPIQ 5 Diagnostic Ultrasound System, EPIQ 7 Diagnostic…Philips Health Care · 2017 · Recalled
- Descendant · 4 generations on · 27 of its ownK181485 EPIQ , EPIQ 5, EPIQ 7, Affiniti 30, Affiniti 50 and Affiniti 70…Philips Ultrasound, Inc. · 2018 · Recalled
- Descendant · 5 generations on · 24 of its ownK200304 EPIQ Diagnostic Ultrasound SystemPhilips Ultrasound, Inc. · 2020 · Recalled
Showing 5 of 41 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 41 · See all- K111245Heartnavigator Release 1Philips Medical Systems Nederland B.V. · 2011 · cites it directly39descendants
- K121781Echonavigator Release 1Philips Medical Systems Nederland B.V. · 2012 · 2 generations on32descendants
- K172607Philips EPIQ 5 Diagnostic Ultrasound System, EPIQ 7 Diagnostic Ultrasound System…Philips Health Care · 2017 · 3 generations on28descendants
- K181485EPIQ , EPIQ 5, EPIQ 7, Affiniti 30, Affiniti 50 and Affiniti 70 Diagnostic Ultrasound…Philips Ultrasound, Inc. · 2018 · 4 generations on27descendants
- K200304EPIQ Diagnostic Ultrasound SystemPhilips Ultrasound, Inc. · 2020 · 5 generations on24descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K890348 | LC, Cardiac Positioner #B5078A | General Electric Co. | 1989 | 5 |
| −6 | K993037 | LCV+ Version 2 | Ge Medical Systems, Inc. | 2000 | 6 |
| −5 | K020055 | Philips Integris Allura 9 with FD Option | Philips Medical Systems | 2002 | 2 |
| −4 | K022899 | Philips Integris Allura Flat Detector Release 1.0 | Philips Medical Systems North America Co. | 2002 | 8 |
| −3 | K031333 | Philips Integris Allura Flat Detector Release 1.2 | Philips Medical Systems North America, Inc. | 2003 | 25 |
| −2 | K031836 | Philips Fresco Release 1 | Philips Medical Systems North America Co. | 2003 | — |
| −1 | K062650 | EP Navigator Software | Philips Medical Systems | 2006 | — |
| 0 (this device) | K101311 | EP Navigator R3 | Philips Medical Systems North America Co. | 2010 | — |
| +1 | K111245 | Heartnavigator Release 1 | Philips Medical Systems Nederland B.V. | 2011 | — |
| +2 | K121781 | Echonavigator Release 1 | Philips Medical Systems Nederland B.V. | 2012 | — |
| +3 | K172607 | Philips EPIQ 5 Diagnostic Ultrasound System, EPIQ 7 Diagnostic Ultrasound… | Philips Health Care | 2017 | 31 |
| +4 | K181485 | EPIQ , EPIQ 5, EPIQ 7, Affiniti 30, Affiniti 50 and Affiniti 70 Diagnostic… | Philips Ultrasound, Inc. | 2018 | 24 |
| +5 | K200304 | EPIQ Diagnostic Ultrasound System | Philips Ultrasound, Inc. | 2020 | 3 |
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 | 3 | 0 |
| 2001 | 5 | 0 |
| 2002 | 1 | 0 |
| 2003 | 4 | 0 |
| 2004 | 7 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 4 | 0 |
| 2017 | 1 | 0 |
| 2018 | 3 | 0 |
| 2020 | 4 | 0 |
| 2021 | 2 | 0 |
| 2022 | 2 | 0 |
| 2023 | 2 | 0 |
| 2024 | 5 | 0 |
| 2025 | 8 | 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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K062650 | EP Navigator SoftwareSummary page 1…s Integris 3D-RA, Philips Xper CT, GE Innova Vision Applications Manufacturer:-.............Philips and GE 510O(k) numbers:-............K062650, K042293,K1(42334, K040254, K060749, K(092639 Appendix 006 510(… | 2006 |
| * | K042293 | Brilliance CT, Private Practice CV Configuration, CT ScannerSummary page 1…s 3D-RA, Philips Xper CT, GE Innova Vision Applications Manufacturer:-.............Philips and GE 510O(k) numbers:-............K062650, K042293,K1(42334, K040254, K060749, K(092639 Appendix 006 510(k) Summar… | 2004 |
| Kept off the family tree | K042334 | FDA’s K042334 is Allura 3D-CA, Release 1 Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2004 |
| * | K040254 | Integris 3D-RA, Release 4.2Summary page 1…Philips Xper CT, GE Innova Vision Applications Manufacturer:-.............Philips and GE 510O(k) numbers:-............K062650, K042293,K1(42334, K040254, K060749, K(092639 Appendix 006 510(k) Summary… | 2004 |
| * | K060749 | XperctSummary page 1…Philips Xper CT, GE Innova Vision Applications Manufacturer:-.............Philips and GE 510O(k) numbers:-............K062650, K042293,K1(42334, K040254, K060749, K(092639 Appendix 006 510(k) Summary Pag… | 2006 |
| * | K092639 | Innova Vision, Model S18751VN, Innova Trackvision, Model S18751VT, Innova Epvision…Summary page 1…sion Applications Manufacturer:-.............Philips and GE 510O(k) numbers:-............K062650, K042293,K1(42334, K040254, K060749, K(092639 Appendix 006 510(k) Summary Page 1 of 3 Philips Medical… | 2009 |
What descends from it? (41)
See all 413 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 21 years and passes through 5 companies; a new generation was cleared every 2.1 years on median.
- 24 of the 50 ancestors have a recall of any class.
- Of its descendants, K111245 (Philips Medical Systems Nederland B.V., 2011) has gone furthest, with 39 descendants of its own.
- 1 other device also cites its predicate K062650.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
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?
EPnavigator is intended to provide navigation support for intra-cardiac instruments, such as catheters and guidewires, during the interventional treatment of heart rhythm disorders, by overlaying acquired and segmented 3D anatomical image data over live fluoroscopic X-ray images of the same anatomy. EPnavigator is intended to be used with patients who suffer from heart rhythm disorders and who are capable of undergoing a procedure guided by X-ray…
Read the full statement (216 words)
EPnavigator is intended to provide navigation support for intra-cardiac instruments, such as catheters and guidewires, during the interventional treatment of heart rhythm disorders, by overlaying acquired and segmented 3D anatomical image data over live fluoroscopic X-ray images of the same anatomy.
EPnavigator is intended to be used with patients who suffer from heart rhythm disorders and who are capable of undergoing a procedure guided by X-ray fluoroscopy.
The heart and surrounding tissue are illuminated by X-ray fluoroscopy (by the Allura Xper system).
The Operator is a Radiologist or Cardiologist who is fully skilled and responsible for sound clinical judgment and for applying the best clinical procedure. The Operator may also be a nurse assisting who is authorized by the Radiologist or Cardiologist.
EPnavigator is to be used in a controlled environment in the context of a control room of a Cathlab. The system is connected to an Allura Xper system.
Within the mentioned patient population, there are no contra-indications.
EPnavigator is intended to enable users to segment previously acquired 3D CT or other datasets and overlay and register these 3D segmented data sets with live fluoroscopy X-ray images of the same anatomy in order to support catheter/device navigation. The 3D segmented data set can be displayed with a color map annotation received from an external source.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K101311 · printed Nov 4, 2026
Cite this page
510(k) Report. “K101311: EP Navigator R3.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K101311
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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