# K212322: Cellvizio I.V.E. system with Confocal Miniprobes

- Pathway: 510(k) (Special)
- Applicant: Mauna Kea Technologies
- Decided: Aug 18, 2021 after 23 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: 13 generations back to K935844 (1995). 83 ancestors in all.
No later device cites it as a predicate yet.
1 of 84 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K191144: Cellvizio 100 Series System with Confocal Miniprobes, Mauna Kea Technologies (2020) Summary page 5.

## Indications for use
The Cellvizio® [.V.E. 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 and vessels and their organization or architecture. The Cellvizio® I.V.E. system is indicated for imaging blood flow in vascular areas, including microvasculature and capillaries. The GastroFlex™ N and ColoFlex™ N Confocal Miniprobes™ are intended to allow imaging of anatomical tracts, i.e., gastrointestinal systems, accessed by an endoscope or endoscopic accessories. The AlveoFlex™ N Confocal Miniprobes™ are intended to allow imaging of anatomical tracts, i.e., respiratory systems, accessed by an endoscope or endoscopic accessories. The CholangioFlex™ N Confocal Miniprobes™ are 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 N Confocal Miniprobes™ are 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 but not limited to EUS-FNA, EBUS-TBNA and TBNA). The CystoFlex™ F N, CystoFlex™ R N and UroFlex™ N 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™ 5 N Confocal Miniprobes™ are intended to provide visualization of body cavities, organs, and canals during endoscopic and laparoscopic surgical procedures, including robot-assisted procedures.

Source page: https://510kreport.com/device/K212322
Methodology: https://510kreport.com/methodology