Cleared Special

InkSpace Imaging Body Array

K223487 · Inkspace Imaging, Inc. · Radiology
Dec 2022
Decision
17d
Days
Class 2
Risk

About This 510(k) Submission

K223487 is an FDA 510(k) clearance for the InkSpace Imaging 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 8, 2022, 17 days after receiving the submission on November 21, 2022. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1000.

Submission Details

510(k) Number K223487 FDA.gov
FDA Decision Cleared SESE
Date Received November 21, 2022
Decision Date December 08, 2022
Days to Decision 17 days
Submission Type Special
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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