Cleared Traditional

InkSpace Imaging Pediatric Body Array

K213397 · Inkspace Imaging, Inc. · Radiology
Dec 2021
Decision
60d
Days
Class 2
Risk

About This 510(k) Submission

K213397 is an FDA 510(k) clearance for the InkSpace Imaging Pediatric Body Array, a Coil, Magnetic Resonance, Specialty (Class II — Special Controls, product code MOS), submitted by Inkspace Imaging, Inc. (Pleasanton, US). The FDA issued a Cleared decision on December 17, 2021, 60 days after receiving the submission on October 18, 2021. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1000.

Submission Details

510(k) Number K213397 FDA.gov
FDA Decision Cleared SESE
Date Received October 18, 2021
Decision Date December 17, 2021
Days to Decision 60 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code MOS — Coil, Magnetic Resonance, Specialty
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.1000

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