K242119

INNOVISION-EXII

510(k) number
K242119
Device name
INNOVISION-EXII
Applicant
Dk Medical System KR
Product code
KPR — System, X-Ray, Stationary
Decision date
2025-01-03
Date received
2024-07-19
Decision
Substantially Equivalent
Clearance type
Traditional
Advisory committee
Radiology
PDFDownload 510(k) SummaryArchived here · 1.4 MB · U.S. public domain

Also available from FDA: K242119.pdf

Official FDA record: K242119
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.