Cleared Special

InkSpace Imaging Small Body Array (SBA12PH30x)

K253182 · Inkspace Imaging, Inc. · Radiology
Oct 2025
Decision
24d
Days
Class 2
Risk

About This 510(k) Submission

K253182 is an FDA 510(k) clearance for the InkSpace Imaging Small Body Array (SBA12PH30x), 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 October 20, 2025, 24 days after receiving the submission on September 26, 2025. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1000.

Submission Details

510(k) Number K253182 FDA.gov
FDA Decision Cleared SESE
Date Received September 26, 2025
Decision Date October 20, 2025
Days to Decision 24 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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