# K172844: Cellvizio 100 Series System with Confocal Miniprobes

- Pathway: 510(k) (Traditional)
- Applicant: Mauna Kea Technologies
- Decided: Dec 15, 2017 after 87 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: 10 generations back to K935844 (1995). 77 ancestors in all.
6 later devices descend from it; 3 cite it directly.
1 of 84 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111047: Cellvizio 100 Series System with Confocal Miniprobes, Mauna Kea Technologies, Inc. (2011) Summary page 4.
- K122042: Cellvizio 100 Series and Cellvizio Systems with Confocal Miniprobes, Mauna Kea Technologies (2012) Summary page 4.
- K123676: Cellvizio 100 Series and Cellvizio Systems with Confocal Miniprobes, Mauna Kea Technologies (2013) Summary page 4.
- K133466: Cellvizio 100 Series System with Confocal Miniprobes (TM), Mauna Kea Technologies (2014) Summary page 4.
- K150831: Cellvizio 100 Series System with Confocal Miniprobes, Mauna Kea Technologies (2015) Summary page 4.
- K151593: Cellvizio 100 Series System with Confocal Miniprobes, Mauna Kea Technologies (2015) Summary page 4.
- K160416: CystoFlex UHD R-C, CelioFlex UHD 5-C, Cellvizio 100 Series (800) with Confocal Miniprobes, Mauna Kea Technologies (2016) Summary page 4.
- K171345: Cellvizio 100 Series Systems with Confocal Miniprobes, Mauna Kea Technologies (2017) Summary page 4.

## Most influential descendants
- 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
- 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
The Cellvizio® 100 Series systems (400 and/or 800) 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 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™ (or GastroFlex™ M) series of 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 Confocal Miniprobe™ is intended to allow imaging of anatomical tracts, i.e., gastrointestinal tracts, accessed by an endoscope or endoscopic accessories, including through EUS-FNA needles. The CystoFlex™ (F, UHD R, UHD R-C) 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, UHD 5-C) of 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/K172844
Methodology: https://510kreport.com/methodology