Mr. Gan · haixiao@sungolytest.com · +86 158 2169 5110 · +86 132 4819 8029Mr. Luo · jun.luo@sungoglobal.com · +86 177 5560 4650

K241273

FullFocus

510(k) number
K241273
Device name
FullFocus
Applicant
Paige.Ai, Inc. NY · US
Product code
QKQ — Digital Pathology Image Viewing And Management Softw
Decision date
2025-01-09
Date received
2024-05-06
Decision
Substantially Equivalent
Clearance type
Traditional
Advisory committee
Pathology
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain

Also available from FDA: K241273.pdf

Official FDA record: K241273
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.