# K122042: Cellvizio 100 Series and Cellvizio Systems with Confocal Miniprobes

- Pathway: 510(k) (Traditional)
- Applicant: Mauna Kea Technologies
- Decided: Sep 4, 2012 after 54 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: 3 generations back to K963354 (1997). 4 ancestors in all.
8 later devices descend from it; 2 cite it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120208: Cellvizio 100 Series System and Cellvizio System with Confocal Miniprobes, Mauna Kea Technologies (2012) Summary page 1.
- K050403: Spyglass Direct Visulation Probe, Boston Scientific Corp (2005) Summary page 1.
- K052194: Spyglass Direct Visualization Probe and Ocular, Boston Scientific Corp (2005) Summary page 1.

## Most influential descendants
- K150831: Cellvizio 100 Series System with Confocal Miniprobes (2015), 7 descendants of its own
- K172844: Cellvizio 100 Series System with Confocal Miniprobes (2017), 6 descendants of its own
- K183640: Cellvizio 100 Series Confocal laser Imaging systems and their Confocal Miniprobes (2019), 4 descendants of its own
- K191144: Cellvizio 100 Series System with Confocal Miniprobes (2020), 2 descendants of its own
- K243711: Confocal Microprobe Imaging System (BrightP980); Confocal Microprobe Imaging System (BrightP960); Confocal Microprobe Imaging System (BrightP880); Confocal Microprobe Imaging System (BrightP860); Confocal Microprobe Imaging System (BrightP780); Confocal Microprobe Imaging System (BrightP750); Confocal Microprobe Imaging System (BrightP680); Confocal Microprobe Imaging System (BrightP660); Confocal Microprobe Imaging System (BrightP600); Confocal Microprobe Imaging System (BrightP580); (2025), 0 descendants of its own

## Indications for use
The GastroFlex M series of Confocal Miniprobes are intended to allow imaging of the internal microstructure of tissues in the upper gastrointestinal tract including biliary and pancreatic ducts, accessed by an endoscope or endoscopic accessories.

Source page: https://510kreport.com/device/K122042
Methodology: https://510kreport.com/methodology