# K191394: ILLUMISITE Platform

- Pathway: 510(k) (Traditional)
- Applicant: Covidien, LLC
- Decided: Aug 7, 2019 after 75 days
- Product code: JAK (System, X-Ray, Tomography, Computed)
- Device class: 2
- Regulation: 21 CFR 892.1750
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 14 generations back to K926514 (1993). 22 ancestors in all.
No later device cites it as a predicate yet.
1 of 23 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K173244: superDimension Navigation System V7.2, Covidien, LLC (2018) Summary page 4.

## Recalls of this device
- May 22, 2023 · Class II · Z-2008-2023: Single ILLUMISITE Platform Console was converted from a 220-240VAC model to a 120VAC configuration using a non-supplied power cord and non-supplied fuses in the field by Medtronic Field Service Engine

## Indications for use
Indicated for displaying images of the tracheobronchial tree to aid the physician in guiding endoscopic tools or catheters in the pulmonary tract and to enable marker placement within soft lung tissue. It does not make a diagnosis and is not an endoscopic tool. Not for pediatric use.

Source page: https://510kreport.com/device/K191394
Methodology: https://510kreport.com/methodology