# K111245: Heartnavigator Release 1

- Pathway: 510(k) (Abbreviated)
- Applicant: Philips Medical Systems Nederland B.V.
- Decided: Jul 29, 2011 after 87 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K890348 (1989). 51 ancestors in all.
39 later devices descend from it; 4 cite it directly.
0 of 91 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101311: EP Navigator R3, Philips Medical Systems North America Co. (2010) Summary page 1.
- K060749: Xperct, Philips Medical Systems North America Co. (2006) Summary page 1.

## Most influential descendants
- K121781: Echonavigator Release 1 (2012), 32 descendants of its own
- K172607: Philips EPIQ 5 Diagnostic Ultrasound System, EPIQ 7 Diagnostic Ultrasound System, Affiniti 30 Diagnostic Ultrasound System, Affiniti 50 Diagnostic Ultrasound System, Affiniti 70 Diagnostic Ultrasound System (2017), 28 descendants of its own
- K181485: EPIQ , EPIQ 5, EPIQ 7, Affiniti 30, Affiniti 50 and Affiniti 70 Diagnostic Ultrasound System (2018), 27 descendants of its own
- K200304: EPIQ Diagnostic Ultrasound System (2020), 24 descendants of its own
- K202216: EPIQ Series Diagnostic Ultrasound Systems (2020), 21 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K111245
Methodology: https://510kreport.com/methodology