4CH Flex Speeder

FDA 510(k) K112366 · Toshiba Medical Systems Coporation, Japan

Substantially Equivalent

510(k) numberK112366

Submission

Device name
4CH Flex Speeder
Applicant
Toshiba Medical Systems Coporation, Japan
Tustin, CA, US
Received
August 17, 2011
Decision date
September 15, 2011
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

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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
K253182InkSpace Imaging Small Body Array (SBA12PH30x)MOS · Special Inkspace Imaging, Inc.10/20/2025SE

More from Inkspace Imaging, Inc.

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K121422Aplio 500/400/300 Diagnostic Ultrasound SystemIYO · Special 08/16/2012SE
K113466Aquilion OneJAK · Traditional 04/10/2012SE
K1112514CH Flex SpeederMOS · Special 05/27/2011SE
K110785Kalare Diagnostic X-Ray Table SystemJAA · Traditional 05/27/2011SE

Questions and answers

When was 4CH Flex Speeder cleared by the FDA?

4CH Flex Speeder (K112366) received a 510(k) decision of Substantially Equivalent on September 15, 2011, 29 days after the submission was received.

What is the product code of K112366?

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