# K220477: Cellvizio 100 series system with confocal Miniprobes

- Pathway: 510(k) (Traditional)
- Applicant: Mauna Kea Technologies
- Decided: Apr 11, 2022 after 52 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: 20 generations back to K930667 (1994). 89 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 91 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K210265: VS3 Iridium Sytem, Visionsense, Ltd. (2021) Summary page 5.

## Most influential descendants
- K251852: cCeLL - In vivo with Drop-In Robo (CN100-2W2C488775, CN100-1W1C775, DR200) (2026), 0 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 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 is indicated for imaging blood flow in vascular areas, including microvasculature and capillaries. Upon intravenous administration and use of an ICG consistent with its approved labeling, the Cellvizio® 100 Series System F800 is used to perform fluorescence angiography. Upon interstitial administration and use of ICG consistent with its approved labeling, the Cellvizio® 100 Series System F800 is used to perform fluorescence imaging and visualization of the lymphatic system, including lymphatic vessels and lymph nodes. Upon administration and use of pafolacianine consistent with its approved labeling, the Cellvizio® 100 Series System F800 is used to perform fluorescence imaging of tissues that have taken up the drug. The GastroFlex™ (UHD, UHD-C) and ColoFlex™ (UHD, UHD-C) Confocal Miniprobes™ are intended to allow imaging of anatomical tracts, i.e., gastrointestinal systems, accessed by an endoscope or endoscopic accessories. The AlveoFlex™ (-, -C) Confocal Miniprobes™ are intended to allow imaging of anatomical tracts, i.e., respiratory systems, accessed by an endoscope or endoscopic accessories. The CholangioFlex™ (-, -C) 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 (-, -C) 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, F-C, and UHD, UHD-C) and UroFlex™ B (-, -C) 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, UHD 5-C) Confocal Miniprobes™ are intended to provide visualization of body cavities, organs, and canals during endoscopic and laparoscopic surgical procedures, including robot-assisted procedures. The CranioFlex™ (-, -C) Confocal Miniprobes™ are indicated to provide visualization within the central nervous system during cranial diagnostic and therapeutic procedures such as tumor biopsy and resection.

Source page: https://510kreport.com/device/K220477
Methodology: https://510kreport.com/methodology