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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
Recalls CDRH Recalls
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