UNIVERSAL DIGITAL INTERFACE WIRELESS – UDI 1417W


Device Classification Name

solid state x-ray imager (flat panel/digital imager)

510(k) Number K111305
Device Name UNIVERSAL DIGITAL INTERFACE WIRELESS – UDI 1417W
Applicant
MERIDIAN MEDICAL SYSTEMS, LLC
325 harris drive
aurora, 
OH 
44202

Applicant Contact ariel marciano
Correspondent
MERIDIAN MEDICAL SYSTEMS, LLC
325 harris drive
aurora, 
OH 
44202

Correspodent Contact ariel marciano
Regulation Number 892.1680
Classification Product Code
MQB  
Date Received 05/09/2011
Decision Date 01/31/2012
Decision

substantially equivalent

(SESE)
Regulation Medical Specialty

Radiology

510k Review Panel

Radiology
statement

statement

Type Traditional
Reviewed by Third Party No
Combination Product

No