Ds Head 32ch 3.0T

Coil, Magnetic Resonance, Specialty

Invivo Corporation (Business Trade Name: Philips)

The following data is part of a premarket notification filed by Invivo Corporation (business Trade Name: Philips) with the FDA for Ds Head 32ch 3.0t.

Pre-market Notification Details

Device IDK213351
510k NumberK213351
Device Name:Ds Head 32ch 3.0T
ClassificationCoil, Magnetic Resonance, Specialty
Applicant Invivo Corporation (Business Trade Name: Philips) 3545 SW 47th Ave Gainesville,  FL  32608
ContactSarah Pleaugh
CorrespondentPrithul Bom
REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul,  MN  55114
Product CodeMOS  
Subsequent Product CodeLNH
Subsequent Product CodeLNI
CFR Regulation Number892.1000 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2021-10-08
Decision Date2021-10-29

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