# K071473: Modification to Superdimension/Bronchus Premium 2

- Pathway: 510(k) (Traditional)
- Applicant: Superdimension, Ltd.
- Decided: Jul 12, 2007 after 44 days
- Product code: EOQ (Bronchoscope (Flexible Or Rigid))
- Device class: 2
- Regulation: 21 CFR 874.4680
- 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 K926514 (1993). 15 ancestors in all.
53 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)
- K062315: Superdimension/Bronchus Premium 2, Superdimension, Ltd. (2006) Summary page 1.

## Most influential descendants
- K080271: Inreach System (2008), 52 descendants of its own
- 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

## Indications for use
Indicated for displaying images of the tracheobronchial tree to aid the physician in guiding endoscopic tools in the pulmonary tract. It does not make a diagnosis and is not an endoscopic tool. Not for pediatric use.

Source page: https://510kreport.com/device/K071473
Methodology: https://510kreport.com/methodology