510(k) K260947

Device: 0.55T 12Ch Breast Coil
Applicant: Neocoil, LLC
510(k) number: K260947
Product code: MOS
Decision: Substantially Equivalent (SESE)
Decision date: 2026-04-23
Date received: 2026-03-23
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: N

Related Records

Applicant Contact

Contact: Judy Yuan
Address: N27 W23910a Paul Rd. Pewaukee WI US 53072 53072

FDA Registration Numbers

3014343100
3014635027
3012169560
3005877899
3005049692
3009196578
3008986341
3021059265
3005326970
1835830
3016851825
3035950510
9616047
3011950073
3008284470
1529041
3000126629
3009755250
3010326005
3015431711
3018423337
2183744
9613936
3026047529
3042177665
1043549
3009077524
3004929307
3015329423
3007137598
3009970070
3021244844
3002808157
3012439308
3009529630
3009656988
1058584
3013875850
3017375271
3023003446
3009963139
3012085143
3008632256
9614698
3006239787
3004754211
3010949642
3007350713
3011015597
3032109225
3014809646
3010132318
3014310698
3007562060
3003768277
1932898
3031503890
3006369484
2183553
3006262888
3004977335
3036666444
3009514037
2011171
3008355361
3015276088
3027339477
3004531751
2029275
3029521953
3009714754
1054811
3008414621
3028006458
3010703925

Source Documents

510(k) summary PDF

Other 510(k) Records For Product Code MOS

510(k)	Device	Applicant	Decision date
K252587	HD 8Ch Wrist Array	Shenzhen RF Tech Co., Ltd.	2026-04-14
K252876	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	Shenzhen RF Tech Co., Ltd.	2026-04-01
K260519	Smart Fit TorsoCardiac 1.5T	Philips Healthcare (Suzhou) Co., Ltd.	2026-03-20
K252179	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	Shenzhen RF Tech Co., Ltd.	2026-02-10
K253738	3.0T AIR 32CH HNA	Ge Healthcare Coils (Usa Instruments, Inc.)	2026-01-23
K254190	dS Base 1.5T; dS Base 3.0T; dS Head 1.5T; dS Head 3.0T; dS HeadNeck 1.5T; dS HeadNeck 3.0T	Philips Medical Systems Nederland B.V.	2026-01-14
K253182	InkSpace Imaging Small Body Array (SBA12PH30x)	Inkspace Imaging, Inc.	2025-10-20
K243428	e2CoilTM Imaging System for the Siemens MAGNETOM 3.0T MRI Systems with Tim 4G Connector	Dxtx Medical, Inc.	2025-07-17
K244054	16ch Flex SPEEDER Medium 1.5T (Q7000246); 16ch Flex SPEEDER Large 1.5T (Q7000247)	Quality Electrodynamics	2025-02-28
K243675	InkSpace Imaging Small Body Array	Inkspace Imaging, Inc.	2024-12-20
K243316	XENOVIEW 3.0T Chest Coil	Polarean, Inc.	2024-11-19
K243033	dS Wrist coil 8ch 1.5T	Philips Medical Systems Nederland B.V.	2024-10-18
K242879	dS Knee Coil 8ch 1.5T	Philips Medical Systems Nederland B.V.	2024-10-18
K242096	dS FootAnkle Coil 8ch 1.5T	Philips Medical Systems Nederland B.V.	2024-08-12
K241069	iLoop Interventional Coil 0.55T	Noras Mri Products GmbH	2024-06-07