K232753

EXPD 4343D; EXPD 3643D

510(k) number
K232753
Device name
EXPD 4343D; EXPD 3643D
Applicant
DRTECH Corporation KR
Product code
MQB — Solid State X-Ray Imager (Flat Panel/Digital Imager)
Decision date
2023-11-16
Date received
2023-09-08
Decision
Substantially Equivalent
Clearance type
Special
Advisory committee
Radiology
PDFDownload 510(k) SummaryArchived here · 2.8 MB · U.S. public domain

Also available from FDA: K232753.pdf

Official FDA record: K232753
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.