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

K222938

Ablation-fit

510(k) number
K222938
Device name
Ablation-fit
Applicant
R.A.W. S.R.L IT
Product code
QTZ — Radiological Image Processing Software For Ablation
Decision date
2023-09-12
Date received
2022-09-26
Decision
Substantially Equivalent
Clearance type
Traditional
Advisory committee
Radiology
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain

Also available from FDA: K222938.pdf

Official FDA record: K222938
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.