K251852

cCeLL - In vivo with Drop-In Robo (CN100-2W2C488775, CN100-1W1C775, DR200)

510(k) number
K251852
Device name
cCeLL - In vivo with Drop-In Robo (CN100-2W2C488775, CN100-1W1C775, DR200)
Applicant
VPIX Medical, Inc. KR
Product code
OWN — Confocal Optical Imaging
Decision date
2026-02-13
Date received
2025-06-17
Decision
Substantially Equivalent
Clearance type
Traditional
Advisory committee
Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 2.9 MB · U.S. public domain

Also available from FDA: K251852.pdf

Official FDA record: K251852
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.