UNIVERSAL DIGITAL INTERFACE (UDI) 1717


Device Classification Name

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

510(k) Number K103599
Device Name UNIVERSAL DIGITAL INTERFACE (UDI) 1717
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 12/08/2010
Decision Date 04/27/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No