510(k) · Cleared
ClearedHeartnavigator Release 1
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Philips Medical Systems Nederland B.V. · LLZ System, Image Processing, Radiological
Cleared on Jul 29, 2011 as substantially equivalent to K101311 (Philips Medical Systems North America Co., 2010) and 1 other predicate after an 87-day review. Its family tree reaches back 8 generations to 1989. 39 later devices descend from it.
- Decided
- Jul 29, 2011
- Review
- 87 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 8 generations to K890348 (1989). 51 ancestors in all, the oldest K852353 (1985). 39 later devices descend from it, 4 citing it directly.
- Root · 8 generations backK890348 LC, Cardiac Positioner #B5078AGeneral Electric Co. · 1989 · Recalled
- 7 generations backK993037 LCV+ Version 2Ge Medical Systems, Inc. · 2000 · Recalled
- 6 generations backK020055 Philips Integris Allura 9 with FD OptionPhilips Medical Systems · 2002 · Recalled
- 5 generations backK022899 Philips Integris Allura Flat Detector Release 1.0Philips Medical Systems North America Co. · 2002 · Recalled
- 4 generations backK031333 Philips Integris Allura Flat Detector Release 1.2Philips Medical Systems North America, Inc. · 2003 · Recalled
- 3 generations backK031836 Philips Fresco Release 1Philips Medical Systems North America Co. · 2003
- 2 generations backK062650 EP Navigator SoftwarePhilips Medical Systems · 2006
- 1 generation backK101311 EP Navigator R3Philips Medical Systems North America Co. · 2010
- This deviceK111245 Heartnavigator Release 1Philips Medical Systems Nederland B.V. · 2011
- Descendant · cites it directly · 32 of its ownK121781 Echonavigator Release 1Philips Medical Systems Nederland B.V. · 2012
- Descendant · 2 generations on · 28 of its ownK172607 Philips EPIQ 5 Diagnostic Ultrasound System, EPIQ 7 Diagnostic…Philips Health Care · 2017 · Recalled
- Descendant · 3 generations on · 27 of its ownK181485 EPIQ , EPIQ 5, EPIQ 7, Affiniti 30, Affiniti 50 and Affiniti 70…Philips Ultrasound, Inc. · 2018 · Recalled
- Descendant · 4 generations on · 24 of its ownK200304 EPIQ Diagnostic Ultrasound SystemPhilips Ultrasound, Inc. · 2020 · Recalled
- Descendant · 5 generations on · 21 of its ownK202216 EPIQ Series Diagnostic Ultrasound SystemsPhilips Ultrasound, Inc. · 2020 · Recalled
Showing 5 of 39 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 39 · See all- K121781Echonavigator Release 1Philips Medical Systems Nederland B.V. · 2012 · cites it directly32descendants
- K172607Philips EPIQ 5 Diagnostic Ultrasound System, EPIQ 7 Diagnostic Ultrasound System…Philips Health Care · 2017 · 2 generations on28descendants
- K181485EPIQ , EPIQ 5, EPIQ 7, Affiniti 30, Affiniti 50 and Affiniti 70 Diagnostic Ultrasound…Philips Ultrasound, Inc. · 2018 · 3 generations on27descendants
- K200304EPIQ Diagnostic Ultrasound SystemPhilips Ultrasound, Inc. · 2020 · 4 generations on24descendants
- K202216EPIQ Series Diagnostic Ultrasound SystemsPhilips Ultrasound, Inc. · 2020 · 5 generations on21descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K890348 | LC, Cardiac Positioner #B5078A | General Electric Co. | 1989 | 5 |
| −7 | K993037 | LCV+ Version 2 | Ge Medical Systems, Inc. | 2000 | 6 |
| −6 | K020055 | Philips Integris Allura 9 with FD Option | Philips Medical Systems | 2002 | 2 |
| −5 | K022899 | Philips Integris Allura Flat Detector Release 1.0 | Philips Medical Systems North America Co. | 2002 | 8 |
| −4 | K031333 | Philips Integris Allura Flat Detector Release 1.2 | Philips Medical Systems North America, Inc. | 2003 | 25 |
| −3 | K031836 | Philips Fresco Release 1 | Philips Medical Systems North America Co. | 2003 | — |
| −2 | K062650 | EP Navigator Software | Philips Medical Systems | 2006 | — |
| −1 | K101311 | EP Navigator R3 | Philips Medical Systems North America Co. | 2010 | — |
| 0 (this device) | K111245 | Heartnavigator Release 1 | Philips Medical Systems Nederland B.V. | 2011 | — |
| +1 | K121781 | Echonavigator Release 1 | Philips Medical Systems Nederland B.V. | 2012 | — |
| +2 | K172607 | Philips EPIQ 5 Diagnostic Ultrasound System, EPIQ 7 Diagnostic Ultrasound… | Philips Health Care | 2017 | 31 |
| +3 | K181485 | EPIQ , EPIQ 5, EPIQ 7, Affiniti 30, Affiniti 50 and Affiniti 70 Diagnostic… | Philips Ultrasound, Inc. | 2018 | 24 |
| +4 | K200304 | EPIQ Diagnostic Ultrasound System | Philips Ultrasound, Inc. | 2020 | 3 |
| +5 | K202216 | EPIQ Series Diagnostic Ultrasound Systems | Philips Ultrasound, Inc. | 2020 | 8 |
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 |
|---|---|---|
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 3 | 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? (2)
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 |
|---|---|---|---|
| * | K101311 | EP Navigator R3Summary page 1…Legally marketed devices Trade names:.................. Philips EP navigator, Philips Xper CT Manufacturer: .................. Philips 510(k) numbers:................ K101311, K060749 Section 006 Page I of 3… | 2010 |
| * | K060749 | XperctSummary page 1…arketed devices Trade names:.................. Philips EP navigator, Philips Xper CT Manufacturer: .................. Philips 510(k) numbers:................ K101311, K060749 Section 006 Page I of 3… | 2006 |
What descends from it? (39)
See all 394 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 22 years and passes through 6 companies; a new generation was cleared every 2.1 years on median.
- 24 of the 51 ancestors have a recall of any class.
- Of its descendants, K121781 (Philips Medical Systems Nederland B.V., 2012) has gone furthest, with 32 descendants of its own.
- 2 other devices also cite its predicate K101311.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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?
Medical purpose: HeartNavigator Release 1 is a tool which assists the user with procedure planning and provides live image guidance in addition to conventional live fluoroscopy guidance for structural heart disease procedures. Patient population: HeartNavigator Release 1 is intended to be used in combination with Allura Xper systems for treating the entire population of patients with structural heart diseases via interventional technologies. Operator…
Read the full statement (126 words)
Medical purpose:
HeartNavigator Release 1 is a tool which assists the user with procedure planning and provides live image guidance in addition to conventional live fluoroscopy guidance for structural heart disease procedures.
Patient population:
HeartNavigator Release 1 is intended to be used in combination with Allura Xper systems for treating the entire population of patients with structural heart diseases via interventional technologies.
Operator profile:
The user is a clinical specialist who is fully skilled and qualified to perform the structural heart disease procedure and is responsible for sound clinical judgment and for applying the best clinical procedure. The user may also be a nurse assisting the clinical specialist. The user must have received adequate training in its safe intended and effective use before operating the HeartNavigator.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K111245 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111245: Heartnavigator Release 1.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111245
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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