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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Nuclear Magnetic Resonance Imaging
510(k) Number K031350
Device Name 3TP SOFTWARE OPTION
Applicant
3tp, LLC
3 Park Ave.
New York,  NY  10016
Applicant Contact VINCENT J MCGILL
Correspondent
3tp, LLC
3 Park Ave.
New York,  NY  10016
Correspondent Contact VINCENT J MCGILL
Regulation Number892.1000
Classification Product Code
LNH  
Date Received04/29/2003
Decision Date 06/23/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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