# K111047: Cellvizio 100 Series System with Confocal Miniprobes

- Pathway: 510(k) (Special)
- Applicant: Mauna Kea Technologies, Inc.
- Decided: Aug 8, 2011 after 115 days
- Product code: OWN (Confocal Optical Imaging)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K926514 (1993). 21 ancestors in all.
12 later devices descend from it; 5 cite it directly.
1 of 34 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051585: F-400 System, Mauna Kea Technologies (2005) Summary page 2.
- K061666: Cellvizio with Confocal Miniprobes, Model F-600; Coloflex and Gastroflex, Mauna Kea Technologies (2006) Summary page 3.

## Most influential descendants
- K132389: Cellvizio 100 Series System and Cellvizio System with Confocal Miniprobes; Uroflex B and Cystolflex F (Both Trade Marked (2014), 10 descendants of its own
- K141358: Cellvizio 100 Series with System Confocal Miniprobes (2014), 9 descendants of its own
- K160416: CystoFlex UHD R-C, CelioFlex UHD 5-C, Cellvizio 100 Series (800) with Confocal Miniprobes (2016), 7 descendants of its own
- K150831: Cellvizio 100 Series System with Confocal Miniprobes (2015), 7 descendants of its own
- K133466: Cellvizio 100 Series System with Confocal Miniprobes (TM) (2014), 7 descendants of its own

## Indications for use
The Cellvizio* 100 Series System with Confocal Miniprobes'" is a confocal laser system with fiber optic probes that is intended to allow imaging of the internal microstructure of tissues in anatomical tracts, i.e., gastrointestinal or respiratory, accessed by an endoscope or endoscopic accessories.

Source page: https://510kreport.com/device/K111047
Methodology: https://510kreport.com/methodology