InkSpace Imaging Pediatric Body Array

Coil, Magnetic Resonance, Specialty

InkSpace Imaging, Inc.

The following data is part of a premarket notification filed by Inkspace Imaging, Inc. with the FDA for Inkspace Imaging Pediatric Body Array.

Pre-market Notification Details

Device IDK213397
510k NumberK213397
Device Name:InkSpace Imaging Pediatric Body Array
ClassificationCoil, Magnetic Resonance, Specialty
Applicant InkSpace Imaging, Inc. 5635 West Las Positas Blvd Suite 403/404 Pleasanton,  CA  94588
ContactPeter Fischer
CorrespondentTaras Bouzakine
Experien Group, LLC 224 Airport Parkway, Suite 250 San Jose,  CA  95110
Product CodeMOS  
CFR Regulation Number892.1000 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-10-18
Decision Date2021-12-17

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