# K062315: Superdimension/Bronchus Premium 2

- Pathway: 510(k) (Special)
- Applicant: Superdimension, Ltd.
- Decided: Sep 8, 2006 after 30 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: 6 generations back to K926514 (1993). 14 ancestors in all.
54 later devices descend from it; 1 cites 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)
- K052852: Superdimension/Bronchus Premium, Superdimension, Ltd. (2005) Summary page 1.

## Most influential descendants
- K071473: Modification to Superdimension/Bronchus Premium 2 (2007), 53 descendants of its own
- 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

## Recalls of this device
- Nov 29, 2006 · Not classified · Z-0666-2007: The action is being taken in response to certain incidents that have been reported to the company, one of which concerned an adverse event in which a patient incurred a pneumothorax during a procedure

## 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/K062315
Methodology: https://510kreport.com/methodology