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

K251363

ProKnow DS

510(k) number
K251363
Device name
ProKnow DS
Applicant
Elekta Solutions AB SE
Product code
LLZ — System, Image Processing, Radiological
Decision date
2025-10-08
Date received
2025-05-01
Decision
Substantially Equivalent
Clearance type
Traditional
Advisory committee
Radiology
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain

Also available from FDA: K251363.pdf

Official FDA record: K251363
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.