# K223918: AltaTrack Equipment R1.2, AltaTrack Guidewire, AltaTrack 3D Hub

- Pathway: 510(k) (Abbreviated)
- Applicant: Philips Medical Systems Nederland B.V.
- Decided: Jun 8, 2023 after 161 days
- Product code: DQK (Computer, Diagnostic, Programmable)
- Device class: 2
- Regulation: 21 CFR 870.1425
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K921310 (1992). 14 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K201081: AltaTrack equipment, AltaTrack Guidewire, AltaTrack Catheter, Philips Medical System Nederland B.V. (2020) Summary page 4.

## Most influential descendants
- K233853: LumiGuide Wire; LumiGuide Equipment R2.0; LumiGuide 3D Hub (2024), 1 descendant of its own
- K252645: LumiGuide Equipment R2.1; LumiGuide Wire; LumiGuide 3D Hub (2025), 0 descendants of its own

## Indications for use
The AltaTrack Equipment is an imaging device with Fiber Optic RealShape (FORS) technology intended to aid the positioning and navigation of a connected AltaTrack Guidewire and, optionally, a catheter during endovascular procedures of the peripheral, aortic and aortic side branch vasculature, by creating a 3D image in real-time of the connected AltaTrack Guidewire and, of an endovascular catheter, when combined with a AltaTrack 3D Hub. The AltaTrack Guidewire is an angiographic guidewire with Fiber Optic RealShape (FORS) technology, intended to direct a catheter during navigation in endovascular procedures of the peripheral, aortic and aortic side branch vasculature. The AltaTrack 3D Hub enables the visualization of a connected endovascular catheter, when used in combination with an AltaTrack Guidewire and the AltaTrack Equipment.

Source page: https://510kreport.com/device/K223918
Methodology: https://510kreport.com/methodology