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

K232412

LungQ v3.0.0

510(k) number
K232412
Device name
LungQ v3.0.0
Applicant
Thirona BV NL
Product code
JAK — System, X-Ray, Tomography, Computed
Decision date
2024-01-08
Date received
2023-08-10
Decision
Substantially Equivalent
Clearance type
Traditional
Advisory committee
Radiology
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain

Also available from FDA: K232412.pdf

Official FDA record: K232412
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.