# K233391: cCeLL - In vivo

- Pathway: 510(k) (Traditional)
- Applicant: VPIX Medical, Inc.
- Decided: Aug 21, 2024 after 324 days
- Product code: GWG (Endoscope, Neurological)
- Device class: 2
- Regulation: 21 CFR 882.1480
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 17 generations back to K930667 (1994). 94 ancestors in all.
No later device cites it as a predicate yet.
0 of 95 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K180146: KARL STORZ ICG Imaging System, Karl Storz Endoscopy America, Inc. (2018) Summary page 5.

## Indications for use
The cCeLL - In vivo is an optic scanner probe placed in direct contact with tissue to create images of the internal microstructure of tissues and is indicated for use with indocyanine green (ICG) for fluorescence imaging as an aid in the visualization of vessels (micro- and macro-vasculature) blood flow in the cerebrovasculature before, during or after cranial diagnostic and therapeutic procedures, such as tumor biopsy and resection.

Source page: https://510kreport.com/device/K233391
Methodology: https://510kreport.com/methodology