Cleared Special

InkSpace Imaging Body Array (K223487) - FDA 510(k) Clearance

Class II Radiology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K223487 · Inkspace Imaging, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2022
Decision
17d
Days
Class 2
Risk

K223487 is an FDA 510(k) clearance for the InkSpace Imaging Body Array. 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 December 8, 2022 after a review of 17 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.

View all Inkspace Imaging, Inc. devices

Submission Details

510(k) Number K223487 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
90d faster than avg
Panel avg: 107d · This submission: 17d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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.
Taras Bouzakine

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 94
Devices cleared under the same product code (MOS) and FDA review panel - the closest regulatory comparables to K223487.
3.0T 16ch AIR AA
K223378 · Ge Healthcare Coils (Usa Instruments, Inc.) · Jan 2023
XENOVIEW 3.0T Chest Coil
K212239 · Polarean, Inc. · Dec 2022
8ch Wrist Coil
K223239 · Shenzhen RF Tech Co., Ltd. · Dec 2022
16ch Breast Coil / 16ch Breast Coils, 1.5T 16ch Breast Coil, 3.0T 16ch Breast Coil, 1.5T 16ch Breast Coil, 3T 16ch Breast Coil
K222407 · Neocoil, LLC · Oct 2022
8ch Wrist Coil
K222325 · Invivo Corporation (Business Trade Name: Philips) · Aug 2022
1.5 T/R Quad Extremity Coil, 1.5T 8CH T/R Knee Coil
K222257 · Invivo Corporation (Business Trade Name: Philips) · Aug 2022