510(k) K231959

EXPD 4357; EXPD 4357P by DRTECH Corporation — Product Code MQB

K231959 is an FDA 510(k) premarket notification submitted by DRTECH Corporation for the device "EXPD 4357; EXPD 4357P". The FDA issued a decision of Substantially Equivalent on August 1, 2023. 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
August 1, 2023
Date Received
July 3, 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