Cleared Special

InkSpace Imaging Small Body Array

K243675 · Inkspace Imaging, Inc. · Radiology
Dec 2024
Decision
23d
Days
Class 2
Risk

About This 510(k) Submission

K243675 is an FDA 510(k) clearance for the InkSpace Imaging Small 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 20, 2024, 23 days after receiving the submission on November 27, 2024. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1000.

Submission Details

510(k) Number K243675 FDA.gov
FDA Decision Cleared SESE
Date Received November 27, 2024
Decision Date December 20, 2024
Days to Decision 23 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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