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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 K232762
Device Name dS Breast Coil 7ch 1.5T
Applicant
Invivo Corporation (Business Trade Name: Philips)
3545 SW 47th Ave.
Gainesville,  FL  32608
Applicant Contact Liselotte Kornmann
Correspondent
REGULATORY TECHNOLOGY SERVICES, LLC
1000 Westgate Drive,
Suite 510k
Saint Paul,  MN  55114
Correspondent Contact Prithul Bom
Regulation Number892.1000
Classification Product Code
MOS  
Date Received09/08/2023
Decision Date 10/03/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party Yes
Combination Product No
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