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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 K213351
Device Name ds Head 32ch 3.0T
Applicant
Invivo Corporation (Business Trade Name: Philips)
3545 SW 47th Ave
gainesville,  FL  32608
Applicant Contact sarah pleaugh
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  
Subsequent Product Codes
LNH   LNI  
Date Received10/08/2021
Decision Date 10/29/2021
Decision substantially equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
summary summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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