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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Coil, Magnetic Resonance, Specialty
510(k) Number K122897
Device Name SENSE HEAD 16 MODEL 800647, SENSE SPINE 16 MODEL 800646; SENSE TORSO 16 MODEL 800645
Applicant
Invivo Corporation
3545 SW 47th Ave.
Florida,  FL  32608
Applicant Contact LANCE AULABAUGH
Correspondent
Invivo Corporation
3545 SW 47th Ave.
Florida,  FL  32608
Correspondent Contact LANCE AULABAUGH
Regulation Number892.1000
Classification Product Code
MOS  
Date Received09/21/2012
Decision Date 12/21/2012
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
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