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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 K222257
Device Name 1.5 T/R Quad Extremity Coil, 1.5T 8CH T/R Knee Coil
Invivo Corporation (Business Trade Name: Philips)
3545 SW 47th Ave.
Gainesville,  FL  32608
Applicant Contact Connie Pascual
1000 Westgate Drive,
Suite 510k
Saint Paul,  MN  55114
Correspondent Contact Prithul Bom
Regulation Number892.1000
Classification Product Code
Date Received07/27/2022
Decision Date 08/23/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No