Chrysalis Intelligence · Product Codes · MOS

MOS · Coil, Magnetic Resonance, Specialty

Radiology · 52 clearances · 15 unique sponsors

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Device class
Class II
Regulation 892.1000
Total clearances
52
2020-01-03 → 2026-07-30
Last 12 months
10
Unique sponsors
15
Classification details
Medical specialty
Radiology
Review panel
RA
Regulation number
892.1000
Implant
N
Life-sustain / support
N
GMP exempt
N
Third-party review
Y
Trend

Clearance volume by quarter

Players

Top sponsors in this product code

Sponsor Clearances Last 12 mo Most recent
Shenzhen RF Tech Co., Ltd. 7 3 2026-04-14
Invivo Corporation (Business Trade Name: Philips) 6 0 2023-10-03
Quality Electrodynamics, LLC 6 0 2025-02-28
Philips Medical Systems Nederland B.V. 6 3 2026-07-30
Inkspace Imaging, Inc. 5 1 2025-10-20
Philips Healthcare (Suzhou) Co., Ltd. 4 1 2026-03-20
Neocoil, LLC 4 1 2026-04-23
Polarean, Inc. 3 0 2024-11-19
Noras Mri Products GmbH 3 0 2024-06-07
Ge Healthcare Coils (Usa Instruments, Inc.) 2 1 2026-01-23
Rapid Biomedical GmbH 2 0 2023-02-01
Invivo Corporation 1 0 2021-12-23
Philips Medical System Nederlands B.V. 1 0 2023-10-24
Insight Medbotics, Inc. 1 0 2023-07-20
Dxtx Medical, Inc. 1 0 2025-07-17
Reimbursement

Likely billing codes (AI-inferred · verify with billing)

Healthcare providers using this device would typically bill under these HCPCS Level II (alphanumeric) or CPT (5-digit) codes. Mapping inferred from device function by Claude Haiku; official descriptions pulled from the CMS HCPCS April 2026 quarterly file where available. Always verify with billing/coding teams before relying on these.

CodeTypeDescriptionConfidenceRationale
A4643 HCPCS — Medium Magnetic resonance imaging coil, specialized
Pulse

Most recent 510(k) clearances

DateK-numberSponsorDevice
2026-07-30 K262330 Philips Medical Systems Nederland B.V. dS 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 3.0T
2026-07-24 K262294 Philips Medical Systems Nederland B.V. dS FootAnkle 16Ch 1.5T;dS FootAnkle 16Ch 3.0T;dS HiRes Hand/Wrist 16Ch 1.5T;dS HiRes Hand/Wrist 16CH 3.0T;dS Small Extremity 16Ch 1.5T;dS Small Extremity 16Ch 3.0T
2026-04-23 K260947 Neocoil, LLC 0.55T 12Ch Breast Coil
2026-04-14 K252587 Shenzhen RF Tech Co., Ltd. HD 8Ch Wrist Array
2026-04-01 K252876 Shenzhen RF Tech Co., Ltd. GEM 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 Only
2026-03-20 K260519 Philips Healthcare (Suzhou) Co., Ltd. Smart Fit TorsoCardiac 1.5T
2026-02-10 K252179 Shenzhen RF Tech Co., Ltd. GEM 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 Only
2026-01-23 K253738 Ge Healthcare Coils (Usa Instruments, Inc.) 3.0T AIR 32CH HNA
2026-01-14 K254190 Philips Medical Systems Nederland B.V. dS Base 1.5T; dS Base 3.0T; dS Head 1.5T; dS Head 3.0T; dS HeadNeck 1.5T; dS HeadNeck 3.0T
2025-10-20 K253182 Inkspace Imaging, Inc. InkSpace Imaging Small Body Array (SBA12PH30x)
2025-07-17 K243428 Dxtx Medical, Inc. e2CoilTM Imaging System for the Siemens MAGNETOM 3.0T MRI Systems with Tim 4G Connector
2025-02-28 K244054 Quality Electrodynamics 16ch Flex SPEEDER Medium 1.5T (Q7000246); 16ch Flex SPEEDER Large 1.5T (Q7000247)
2024-12-20 K243675 Inkspace Imaging, Inc. InkSpace Imaging Small Body Array
2024-11-19 K243316 Polarean, Inc. XENOVIEW 3.0T Chest Coil
2024-10-18 K243033 Philips Medical Systems Nederland B.V. dS Wrist coil 8ch 1.5T
2024-10-18 K242879 Philips Medical Systems Nederland B.V. dS Knee Coil 8ch 1.5T
2024-08-12 K242096 Philips Medical Systems Nederland B.V. dS FootAnkle Coil 8ch 1.5T
2024-06-07 K241069 Noras Mri Products GmbH iLoop Interventional Coil 0.55T
2024-02-16 K233652 Quality Electrodynamics Contour Hand/Wrist (Q7000232)
2024-02-15 K233656 Quality Electrodynamics Contour Shoulder
2024-02-05 K233600 Philips Healthcare (Suzhou) Co., Ltd. Smart Fit Knee 3.0T
2024-01-08 K233444 Inkspace Imaging, Inc. InkSpace Imaging Small Body Array
2023-10-24 K233348 Philips Medical System Nederlands B.V. 16 Breast Coil
2023-10-03 K232762 Invivo Corporation (Business Trade Name: Philips) dS Breast Coil 7ch 1.5T
2023-09-01 K232021 Philips Healthcare (Suzhou) Co., Ltd. Smart Fit TorsoCardiac 1.5T and Smart Fit Shoulder 1.5T
Data source: openFDA · Generated 2026-08-28 09:16 · Last ingest 2026-08-28T13:16:47.116226 · Pipeline: Chrysalis Intelligence