510(k) K112527

UNIVERSAL DIGITAL INTERFACE (UDI) 1717 by Meridian Medical Systems, LLC — Product Code MQB

K112527 is an FDA 510(k) premarket notification submitted by Meridian Medical Systems, LLC for the device "UNIVERSAL DIGITAL INTERFACE (UDI) 1717". The FDA issued a decision of Substantially Equivalent on May 22, 2012. 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
May 22, 2012
Date Received
August 31, 2011
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