InkSpace Imaging Small Body Array (SBA12PH30x)

FDA 510(k) K253182 · Inkspace Imaging, Inc.

Substantially Equivalent

510(k) numberK253182

Submission

Device name
InkSpace Imaging Small Body Array (SBA12PH30x)
Applicant
Inkspace Imaging, Inc.
Pleasanton, CA, US
Received
September 26, 2025
Decision date
October 20, 2025
Decision
Substantially Equivalent (SESE)
Type
Special 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
MOS – Coil, Magnetic Resonance, Specialty
Device class
Class II (moderate risk)
Regulation
21 CFR 892.1000
Specialty
Radiology

Other 510(k)s with product code MOS

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K262330dS Breast 7ch 1.5TdS Breast 7ch 3.0TdS Breast 16ch 1.5TdS Breast 16ch 3.0TdS Breast Coil…MOS · Special Philips Medical Systems Nederland B.V.07/30/2026SE
K262294dS FootAnkle 16Ch 1.5T;dS FootAnkle 16Ch 3.0T;dS HiRes Hand/Wrist 16Ch 1.5T;dS HiRes…MOS · Special Philips Medical Systems Nederland B.V.07/24/2026SE
K2609470.55T 12Ch Breast CoilMOS · Special Neocoil, LLC04/23/2026SE
K252587HD 8Ch Wrist ArrayMOS · Traditional Shenzhen RF Tech Co., Ltd.04/14/2026SE
K252876GEM Flex Coil 16-L Array, 3.0T Receive Only; GEM Flex Coil 16-M Array, 3.0T Receive…MOS · Traditional Shenzhen RF Tech Co., Ltd.04/01/2026SE
K260519Smart Fit TorsoCardiac 1.5TMOS · Special Philips Healthcare (Suzhou) Co., Ltd.03/20/2026SE
K252179GEM Flex Coil 16-L Array, 1.5T Receive Only; GEM Flex Coil 16-M Array, 1.5T Receive…MOS · Traditional Shenzhen RF Tech Co., Ltd.02/10/2026SE
K2537383.0T Air 32CH HnaMOS · Abbreviated Ge Healthcare Coils (Usa Instruments, Inc.)01/23/2026SE
K254190dS Base 1.5T; dS Base 3.0T; dS Head 1.5T; dS Head 3.0T; dS HeadNeck 1.5T; dS HeadNeck 3.0TMOS · Special Philips Medical Systems Nederland B.V.01/14/2026SE
K243428e2CoilTM Imaging System for the Siemens MAGNETOM 3.0T MRI Systems with Tim 4G ConnectorMOS · Abbreviated Dxtx Medical, Inc.07/17/2025SE

More from Dxtx Medical, Inc.

510(k)DeviceDecision
K243675InkSpace Imaging Small Body ArrayMOS · Special 12/20/2024SE
K233444InkSpace Imaging Small Body ArrayMOS · Special 01/08/2024SE
K223487InkSpace Imaging Body ArrayMOS · Special 12/08/2022SE
K213397InkSpace Imaging Pediatric Body ArrayMOS · Traditional 12/17/2021SE

Questions and answers

When was InkSpace Imaging Small Body Array (SBA12PH30x) cleared by the FDA?

InkSpace Imaging Small Body Array (SBA12PH30x) (K253182) received a 510(k) decision of Substantially Equivalent on October 20, 2025, 24 days after the submission was received.

What is the product code of K253182?

The FDA product code is MOS – Coil, Magnetic Resonance, Specialty, a Class II (moderate risk) device regulated under 21 CFR 892.1000.