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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name image-intensified fluoroscopic x-ray system, mobile
510(k) Number K981131
Device Name PATHFINDER MOBILE C ARM
Applicant
ACOMA MEDICAL IMAGING, INC.
150 CHADDICK DR.
WHEELING,  IL  60090
Applicant Contact JAMES LAMBRECHT
Correspondent
ACOMA MEDICAL IMAGING, INC.
150 CHADDICK DR.
WHEELING,  IL  60090
Correspondent Contact JAMES LAMBRECHT
Regulation Number892.1650
Classification Product Code
OXO  
Date Received03/30/1998
Decision Date 06/26/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Statement Statement
Type Abbreviated
Reviewed by Third Party No
Combination Product No
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