# K183640: Cellvizio 100 Series Confocal laser Imaging systems and their Confocal Miniprobes

- Pathway: 510(k) (Special)
- Applicant: Mauna Kea Technologies
- Decided: Feb 22, 2019 after 58 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: 11 generations back to K935844 (1995). 78 ancestors in all.
4 later devices descend from it; 2 cite it directly.
1 of 83 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123676: Cellvizio 100 Series and Cellvizio Systems with Confocal Miniprobes, Mauna Kea Technologies (2013) Summary page 4.
- K150831: Cellvizio 100 Series System with Confocal Miniprobes, Mauna Kea Technologies (2015) Summary page 4.
- K172844: Cellvizio 100 Series System with Confocal Miniprobes, Mauna Kea Technologies (2017) Summary page 4.

## Most influential descendants
- 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
- K241275: Histolog® Scanner  (Hardware 2.4, Software 3.3) (2024), 0 descendants of its own
- K212322: Cellvizio I.V.E. system with Confocal Miniprobes (2021), 0 descendants of its own

## Indications for use
Cellvizio® 100 Series System with Confocal Miniprobes™ are confocal laser systems with fiber optic probes that are intended to allow imaging of the internal microstructure of tissues including, but not limited to, the identification of cells and vessels and their organization or architecture. The AQ-Flex™ 19 Confocal Miniprobe™ is intended to allow imaging of anatomical tracts, i.e., gastrointestinal and respiratory tracts, accessed by an endoscope, or endoscopic accessories (e.g aspiration needles used during procedures including EUS-FNA, EBUS-TBNA and TBNA needles).

Source page: https://510kreport.com/device/K183640
Methodology: https://510kreport.com/methodology