Cleared Special

K262813 - InkSpace Imaging Small Body Array (SBA12PH15x)

K262813 is an FDA 510(k) clearance for InkSpace Imaging Small Body Array (SBA1..., manufactured by Inkspace Imaging, Inc.. The device is a Class 2 Radiology device with product code MOS cleared through the Special 510(k) pathway after a 59-day FDA review.

K262813 · Inkspace Imaging, Inc. · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2026
Decision
59d
Days
Class 2
Risk

K262813 is an FDA 510(k) clearance for the InkSpace Imaging Small Body Array (SBA12PH15x). Classified as Coil, Magnetic Resonance, Specialty (product code MOS), Class II - Special Controls.

Submitted by Inkspace Imaging, Inc. (Pleasanton, US). The FDA issued a Cleared decision on October 5, 2026 after a review of 59 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1000 - the FDA radiology and imaging software oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K262813

510(k) Number K262813 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 07, 2026
Decision Date October 05, 2026
Days to Decision 59 days
Submission Type Special
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
48d faster than avg
Panel avg: 107d · This submission: 59d
Pathway characteristics
Modification to existing cleared device.

MOS Device Classification - Class 2, Special Controls

Product Code MOS Coil, Magnetic Resonance, Specialty
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1000
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Consultant

Veranex, Inc.
Welkin Collins

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - MOS Coil, Magnetic Resonance, Specialty

All 490
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K262813 · InkSpace Imaging Small Body Array (SBA12PH15x)
Download PDF FDA Summary Inkspace Imaging, Inc.