FDA.reportPublic FDA data

510(k) K242879

Device
dS Knee Coil 8ch 1.5T
Applicant
Philips Medical Systems Nederland B.V.
510(k) number
K242879
Product code
MOS
Decision
Substantially Equivalent (SESE)
Decision date
2024-10-18
Date received
2024-09-23
Regulation
892.1000
Classification name
Coil, Magnetic Resonance, Specialty
Medical specialty
Radiology
Review panel
Radiology
Device class
2
Clearance type
Special
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Asha Jacob
Address
Veenpluis 6 Best NL 5684PC 5684PC

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code MOS#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K262330dS Breast 7ch 1.5TdS Breast 7ch 3.0TdS Breast 16ch 1.5TdS Breast 16ch 3.0TdS Breast Coil 7ch 1.5TdS Sentinelle Breast 16ch 1.5TdS Sentinelle Breast 16ch 3.0TPhilips Medical Systems Nederland B.V.2026-07-30
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K2609470.55T 12Ch Breast CoilNeocoil, LLC2026-04-23
K252587HD 8Ch Wrist ArrayShenzhen RF Tech Co., Ltd.2026-04-14
K252876GEM Flex Coil 16-L Array, 3.0T Receive Only; GEM Flex Coil 16-M Array, 3.0T Receive Only; GEM Flex Coil 16-S Array, 3.0T Receive OnlyShenzhen RF Tech Co., Ltd.2026-04-01
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K252179GEM Flex Coil 16-L Array, 1.5T Receive Only; GEM Flex Coil 16-M Array, 1.5T Receive Only; GEM Flex Coil 16-S Array, 1.5T Receive OnlyShenzhen RF Tech Co., Ltd.2026-02-10
K2537383.0T AIR 32CH HNAGe Healthcare Coils (Usa Instruments, Inc.)2026-01-23
K254190dS Base 1.5T; dS Base 3.0T; dS Head 1.5T; dS Head 3.0T; dS HeadNeck 1.5T; dS HeadNeck 3.0TPhilips Medical Systems Nederland B.V.2026-01-14
K253182InkSpace Imaging Small Body Array (SBA12PH30x)Inkspace Imaging, Inc.2025-10-20
K243428e2CoilTM Imaging System for the Siemens MAGNETOM 3.0T MRI Systems with Tim 4G ConnectorDxtx Medical, Inc.2025-07-17
K24405416ch Flex SPEEDER Medium 1.5T (Q7000246); 16ch Flex SPEEDER Large 1.5T (Q7000247)Quality Electrodynamics2025-02-28
K243675InkSpace Imaging Small Body ArrayInkspace Imaging, Inc.2024-12-20
K243316XENOVIEW 3.0T Chest CoilPolarean, Inc.2024-11-19
K243033dS Wrist coil 8ch 1.5TPhilips Medical Systems Nederland B.V.2024-10-18