510(k) K232082

EXPD 4343S by DRTECH Corporation — Product Code MQB

K232082 is an FDA 510(k) premarket notification submitted by DRTECH Corporation for the device "EXPD 4343S". The FDA issued a decision of Substantially Equivalent on February 13, 2024. The device falls under product code MQB (Solid State X-Ray Imager (Flat Panel/Digital Imager)), a Class II device regulated under 21 CFR 892.1680. DRTECH Corporation has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 13, 2024
Date Received
July 13, 2023
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Solid State X-Ray Imager (Flat Panel/Digital Imager)
Device Class
Class II
Regulation Number
892.1680
Review Panel
RA
Submission Type