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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name system, x-ray, mobile
510(k) Number K862452
Device Name MX MOBILE X-RAY SYSTEM
Applicant
PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.
5500 AVION PARK DR.
HIGHLAND HEIGHTS,  OH  44143
Applicant Contact WILLIAM GERBER
Correspondent
PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.
5500 AVION PARK DR.
HIGHLAND HEIGHTS,  OH  44143
Correspondent Contact WILLIAM GERBER
Regulation Number892.1720
Classification Product Code
IZL  
Date Received06/27/1986
Decision Date 07/22/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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