510(k) K143232

Universal Digital Interface 2W, UDI 2W by Meridian Medical Systems, LLC — Product Code MQB

K143232 is an FDA 510(k) premarket notification submitted by Meridian Medical Systems, LLC for the device "Universal Digital Interface 2W, UDI 2W". The FDA issued a decision of Substantially Equivalent on January 30, 2015. 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
January 30, 2015
Date Received
November 10, 2014
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