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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 K213735
Device Name dS Sentinelle Breast 16ch 1.5T Coil
Applicant
Invivo Corporation (Business Trade Name: Philips)
3545 SW 47th Ave.
Florida,  FL  32608
Applicant Contact Ann Lebar
Correspondent
Invivo Corporation (Business Trade Name: Philips)
3545 SW 47th Ave.
Florida,  FL  32608
Correspondent Contact Jennifer Conyac
Regulation Number892.1000
Classification Product Code
MOS  
Date Received11/29/2021
Decision Date 08/08/2022
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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