# K102604: I-Logic Inreach System

- Pathway: 510(k) (Special)
- Applicant: Superdimension, Ltd.
- Decided: Oct 7, 2010 after 27 days
- Product code: JAK (System, X-Ray, Tomography, Computed)
- Device class: 2
- Regulation: 21 CFR 892.1750
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to K926514 (1993). 19 ancestors in all.
8 later devices descend from it; 2 cite it directly.
1 of 28 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071473: Modification to Superdimension/Bronchus Premium 2, Superdimension, Ltd. (2007) Summary page 1.
- K092365: Inreach System, Model AAS00161-02, Superdimension, Ltd. (2009) Summary page 1.

## Most influential descendants
- K110093: Superdimension Marker Delivery Kit (2011), 4 descendants of its own
- K112051: Lungpoint Planning and Virtual Bronchoscopic Navigation (VBN) Software (2011), 3 descendants of its own
- K151376: superDimension Navigation System (2015), 2 descendants of its own
- K181892: Ziostation2 (2018), 1 descendant of its own
- K173244: superDimension Navigation System V7.2 (2018), 1 descendant of its own

## 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/K102604
Methodology: https://510kreport.com/methodology