# K101311: EP Navigator R3

- Pathway: 510(k) (Traditional)
- Applicant: Philips Medical Systems North America Co.
- Decided: Sep 30, 2010 after 142 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: 7 generations back to K890348 (1989). 50 ancestors in all.
41 later devices descend from it; 3 cite it directly.
0 of 92 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062650: EP Navigator Software, Philips Medical Systems (2006) Summary page 1.
- K042293: Brilliance CT, Private Practice CV Configuration, CT Scanner, Philips Medical Systems (Cleveland), Inc. (2004) Summary page 1.
- K040254: Integris 3D-RA, Release 4.2, Philips Medical Systems North America Co. (2004) Summary page 1.
- K060749: Xperct, Philips Medical Systems North America Co. (2006) Summary page 1.
- K092639: Innova Vision, Model S18751VN, Innova Trackvision, Model S18751VT, Innova Epvision, Model S18751EP, GE Medical Systems SCS (2009) Summary page 1.

## Cited in the summary but kept off the family tree
- K042334: Allura 3D-CA, Release 1, Philips Medical Systems North America Co. (2004). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K111245: Heartnavigator Release 1 (2011), 39 descendants of its own
- 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

## Indications for use
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.

Source page: https://510kreport.com/device/K101311
Methodology: https://510kreport.com/methodology