# K080271: Inreach System

- Pathway: 510(k) (Traditional)
- Applicant: Superdimension, Ltd.
- Decided: Mar 31, 2008 after 59 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: 8 generations back to K926514 (1993). 16 ancestors in all.
52 later devices descend from it; 3 cite it directly.
6 of 69 devices in its family (counting itself) have 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.

## Most influential descendants
- K081379: Modification to Inreach System (2008), 45 descendants of its own
- K083745: The IC-Pro System, Model Version 3.2 (2009), 30 descendants of its own
- K110256: The IC-Pro System (2011), 15 descendants of its own
- K100292: Caas Qva 3D, Caas Qca 3D (2010), 13 descendants of its own
- K091781: Guided Medical Positioning System (GMPS) (2009), 11 descendants 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/K080271
Methodology: https://510kreport.com/methodology