510(k) K140251

UNIVERSAL DIGITAL INTERFACE 2, UDI 2 by Meridian Medical Systems, LLC — Product Code MQB

K140251 is an FDA 510(k) premarket notification submitted by Meridian Medical Systems, LLC for the device "UNIVERSAL DIGITAL INTERFACE 2, UDI 2". The FDA issued a decision of Substantially Equivalent on October 22, 2014. 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. Meridian Medical Systems, LLC has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 22, 2014
Date Received
January 31, 2014
Clearance Type
Traditional
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