# K191144: Cellvizio 100 Series System with Confocal Miniprobes

- Pathway: 510(k) (Traditional)
- Applicant: Mauna Kea Technologies
- Decided: Jan 24, 2020 after 269 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: 12 generations back to K935844 (1995). 82 ancestors in all.
2 later devices descend from it; 2 cite it directly.
1 of 85 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K172844: Cellvizio 100 Series System with Confocal Miniprobes, Mauna Kea Technologies (2017) Summary page 5.
- K180270: Cellvizio 100 Series Systems with Confocal Miniprobes, Mauna Kea Technologies (2018) Summary page 5.
- K183640: Cellvizio 100 Series Confocal laser Imaging systems and their Confocal Miniprobes, Mauna Kea Technologies (2019) Summary page 5.

## Most influential descendants
- 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
- 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™ is a confocal laser system 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, vessels and their organization or architecture. The Cellvizio® 100 Series System F400-v2 is indicated for imaging blood flow in vascular areas, including microvasculature and capillaries. The GastroFlex™ UHD and ColoFlex™ UHD Confocal Miniprobes™ are intended to allow imaging of anatomical tracts, i.e., gastrointestinal systems, accessed by an endoscope or endoscopic accessories. The AlveoFlex™ Confocal Miniprobe™ is intended to allow imaging of anatomical tracts, i.e., respiratory systems, accessed by an endoscope or endoscopic accessories. The CholangioFlex™ series of Confocal Miniprobe™ is intended to allow imaging of the upper gastrointestinal tract including biliary and pancreatic ducts, accessed by an endoscope or endoscopic accessories. 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). The CystoFlex™ (F, UHD-R) and UroFlex™ B of Confocal Miniprobes™ are intended to allow imaging of anatomical tracts, i.e., urinary, including, but not limited to, urethra, bladder, and ureter, accessed through an endoscope or endoscopic accessories. The CelioFlex™ UHD 5 of Confocal Miniprobe™ is intended to provide visualization of body cavities, organs, and canals during endoscopic and laparoscopic surgical procedures, including robot-assisted procedures. The CranioFlex™ Confocal Miniprobe™ is indicated to provide visualization within central nervous system during cranial diagnostic and therapeutic procedures such as tumor biopsy and resection.

Source page: https://510kreport.com/device/K191144
Methodology: https://510kreport.com/methodology