DS FootAnkle 16Ch Coils For 1.5T And 3.0T, DS HiRes HandWrist 16Ch Coils For 1.5T And 3.0T, Ds Small Extremity 16Ch Coils For 1.5T And 3.0T

Coil, Magnetic Resonance, Specialty

Invivo Corporation

The following data is part of a premarket notification filed by Invivo Corporation with the FDA for Ds Footankle 16ch Coils For 1.5t And 3.0t, Ds Hires Handwrist 16ch Coils For 1.5t And 3.0t, Ds Small Extremity 16ch Coils For 1.5t And 3.0t.

Pre-market Notification Details

Device IDK213766
510k NumberK213766
Device Name:DS FootAnkle 16Ch Coils For 1.5T And 3.0T, DS HiRes HandWrist 16Ch Coils For 1.5T And 3.0T, Ds Small Extremity 16Ch Coils For 1.5T And 3.0T
ClassificationCoil, Magnetic Resonance, Specialty
Applicant Invivo Corporation 3545 SW 47th Ave Gainesville,  FL  32608
ContactAnn Lebar
CorrespondentPrithul Bom
REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul,  MN  55114
Product CodeMOS  
CFR Regulation Number892.1000 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2021-12-01
Decision Date2021-12-23

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