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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 K041213
Device Name 3DSCOPE
Applicant
DIREX SYSTEMS CORP.
11 MERCER RD.
NATICK,  MA  01760
Applicant Contact LARISA GERSHTEIN
Correspondent
DIREX SYSTEMS CORP.
11 MERCER RD.
NATICK,  MA  01760
Correspondent Contact LARISA GERSHTEIN
Regulation Number892.1650
Classification Product Code
OXO  
Date Received05/10/2004
Decision Date 07/22/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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