Coil, Magnetic Resonance, Specialty

Product Code: MOS

Radiology Nuclear Magnetic Resonance Devices

Definition: Radiation Emitting Electronic Product Codes // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Co

Applicable Standards: No Standard Applicable. General Radiological Health Requirements Apply. [1000-1005]

Code of Federal Regulations: 892.1000


Radiation TypeMicrowave EMF
Radition SafetyNone
Annual ReportsNo

Products Classified as MOS

5391Coil, Magnetic Resonance, SpecialtyMagnetic Resonance Diagnostic Device.

Total Product Life Cycle (TPLC) Devices

5391Coil, Magnetic Resonance, SpecialtyMagnetic Resonance Diagnostic Device.

FDA Consensus Standards

Coil, Magnetic Resonance, Specialty [37168]21 CFR §892.1000 🔎
Coil, Magnetic Resonance, Specialty [37048]21 CFR §892.1000 🔎
Coil, Magnetic Resonance, Specialty [35654]21 CFR §892.1000 🔎
Coil, Magnetic Resonance, Specialty [34007]21 CFR §892.1000 🔎
Coil, Magnetic Resonance, Specialty [33534]21 CFR §892.1000 🔎
Coil, Magnetic Resonance, Specialty [38515]21 CFR §892.1000 🔎
Coil, Magnetic Resonance, Specialty [32083]21 CFR §892.1000 🔎
Coil, Magnetic Resonance, Specialty [29948]21 CFR §892.1000 🔎
Coil, Magnetic Resonance, Specialty [33533]21 CFR §892.1000 🔎
Coil, Magnetic Resonance, Specialty [33531]21 CFR §892.1000 🔎
Coil, Magnetic Resonance, Specialty [33541]21 CFR §892.1000 🔎
Coil, Magnetic Resonance, Specialty [33530]21 CFR §892.1000 🔎

Pre-market Notifications for MOS

K223487InkSpace Imaging Body ArrayInkSpace Imaging, Inc.
K2232398ch Wrist CoilShenzhen RF Tech Co., Ltd.
K22240716ch Breast Coil / 16ch Breast Coils, 1.5T 16ch Breast Coil, 3.0T 16ch Breast Coil, 1.5T 16ch Breast Coil, 3T 16ch Breast CoilNeoCoil, LLC
K2223258ch Wrist CoilInvivo Corporation (Business Trade Name: Philips)
K220144Breast BI Coil Set 0.55T; Breast BI 7 MR Coil Set 1.5T; Breast BI 7 MR Coil Set 3TNORAS MRI Products GmbH
K213766DS FootAnkle 16Ch Coils For 1.5T And 3.0T, DS HiRes HandWrist 16Ch Coils For 1.5T And 3.0T, Ds Small Extremity 16Ch Coils For 1.5T And 3.0TInvivo Corporation
K213735DS Sentinelle Breast 16ch 1.5T CoilInvivo Corporation (Business Trade Name: Philips)
K213727DS Sentinelle Breast 16ch 3.0T CoilInvivo Corporation (Business Trade Name: Philips)
K21368732Ch AIR Open Coil Suite: 1.5T AIR Open Head Neck Posterior 9ch / 3.0T AIR Open Head Neck Posterior 9ch, 1.5T AIR Open Neck Chest Anterior 7ch / 3.0T AIR Open Neck Chest Anterior 7ch, 1.5T AIR Open Head Anterior 16ch / 3.0T AIR Open Head Anterior 16cNeoCoil, LLC
K213397InkSpace Imaging Pediatric Body ArrayInkSpace Imaging, Inc.
K213351Ds Head 32ch 3.0TInvivo Corporation (Business Trade Name: Philips)
K212864DS TorsoCardiac 1.5T, DS MSK S 1.5T, DS MSK M 1.5TPhilips Healthcare (Suzhou) Co., Ltd
K211658OR Head Holder LUCY With HeadCoilSet Siemens 1.5T, OR Head Holder LUCY With HeadCoilSet Siemens 3T, OR Head Holder LUCY With HeadCoilSet Philips 1.5T, OR Head Holder LUCY With HeadCoilSet Philips 3TNORAS MRI Products GmbH
K2011011.5T 16ch Shoulder Coil, 3.0T 16ch Shoulder CoilNeoCoil, LLC
K2008368ch Flex SuiteShenzhen RF Tech Co., Ltd.

Global Unique Device Identification Database

00616258021072Coil, Magnetic Resonance, Specialty
10616258009268Coil, Magnetic Resonance, Specialty
10616258009251Coil, Magnetic Resonance, Specialty
00616258009179Coil, Magnetic Resonance, Specialty
00616258009162Coil, Magnetic Resonance, Specialty
00616258009148Coil, Magnetic Resonance, Specialty
00616258009131Coil, Magnetic Resonance, Specialty
00616258009117Coil, Magnetic Resonance, Specialty
00616258009100Coil, Magnetic Resonance, Specialty
00616258009087Coil, Magnetic Resonance, Specialty
00616258009070Coil, Magnetic Resonance, Specialty
00616258009025Coil, Magnetic Resonance, Specialty
00616258009018Coil, Magnetic Resonance, Specialty
00616258009001Coil, Magnetic Resonance, Specialty
00814848020676Coil, Magnetic Resonance, Specialty

Maude Adverse Events

QUALITY ELECTRODYNAMICSQUALITY ELECTRODYNAMICS, LLC2020-03-31
DS HEADNECK 3.0TINVIVO CORPORATION2019-12-11
LEOPARD SPINCE COIL 1.5TCARMA SALUD, S.L.2019-09-27
QUALITY ELECTRODYNAMICSQUALITY ELECTRODYNAMICS, LLC2019-08-30
INVIVO CORP DS 3T HEAD COILINVIVO CORP2019-07-26
HITACHI OASIS 1.2T OPEN MR UNITHITACHI MEDICAL SYSTEM OPERATIONS GROUP2019-06-04
KFA, GEHC, SIGNA 1.5T 4CH PACARMA SALUD, S.L.2019-03-28
IMRIS HC300 IOHV2 HEAD FLEX COILDEERFIELD IMAGING, INC.2019-03-12
GE ANTERIOR ARRAY MRI COILGE HEALTHCARE CO., LTD.2019-01-16
MRICOIL, MAGNETIC RESONANCE SPECIALITYUNK2018-12-31
DS HEADNECK COIL 3.0TCARMA SALUD, S.L.2018-12-10
DS BREAST ADAPTIVE 16CH MR COIL - DSTREAMINVIVO CORPORATION2018-11-09
UPG NV TO HEAD-SPINE 1.5TCARMA SALUD, S.L.2018-09-04
LARGE BORE MRIUNK2018-08-02
VNGRD BRST MRI TBLTP COIL 16-CH 3.0TCARMA SALUD, S.L.2018-06-07
SENSE NV COIL 1.5T (16CH)CARMA SALUD, S.L.2018-05-11
SENSE KNEE COIL 1.5T 8CHCARMA SALUD, S.L.2017-11-10
GE 1.5T GEM HNUGE HEALTHCARE2017-10-20
4 CH SENSE SHOULDER COIL 1.5TCARMA SALUD, S.L.2017-08-24
GE SIGNA HD XTGE HEALTHCARE2017-08-03
NOT DETERMINEDCARMA SALUD, S.L.2017-03-28
LARGE FLEX COILGE HEALTHCARE JAPAN CORPORATION2017-01-25
LARGE FLEX COILGE HEALTHCARE JAPAN CORPORATION2017-01-25
MRI - BREAST COIL2017-01-24
GEANTERIOR ARRAY COILGE2017-01-11
MRI 3 T TESLA2016-10-13
NOT DETERMINEDINVIVO CORPORATION2016-09-29
NOT DETERMINEDINVIVO CORPORATION2016-09-01
DS ANTERIOR 1.5TINVIVO CORPORATION2016-07-01
TOSHIBATOSHIBA MEDICAL SYSTEMS CORPORATION2016-07-01
GE SIGNA MRI SCANNERGE MEDICAL SYSTEMS LLC2016-06-01
SENTINELLE ARRAY BREAST COILSINTINELLE VANGUARD2016-01-16
INVIVO/PHILIPSINVIVO/PHILIPS2015-09-04
TOSHIBATOSHIBA MEDICAL SYSTEMS CORPORATION2015-05-01
SENSE SHOULDER COIL 1.5T 4CHINVIVO CORP2015-02-03
DS ANTERIOR 3.0TINVIVO CORP2015-02-03
FRU, HEADNECKSPINE COIL 1.5TINVIVO CORP2015-01-20
SENSE HEAD COIL 1.5T 8 CHINVIVO CORP2014-07-09
TOSHIBATOSHIBA MEDICAL SYSTEMS CORPORATION2014-06-11
INVIVO SENSE XL TORSO MRI COILINVIVO2014-04-14
SENSE BREAST 3.0TINVIVO CORPORATION2014-01-31
QED KNEE COILQED2013-10-31
VANGUARD BREAST MRI AUXILIARY TABLE WITH 8CHSENTINELLE MEDICAL, INC.2013-10-25
VANGUARD BREAST MRI AUXILIARY TABLE WITH 8CHSENTINELLE MEDICAL2013-09-10
SIEMENSMAQUET CRITICAL CARE AB2013-08-29
HITACHI MEDICAL SYSTEMSHITACHI MEDICAL CORP2013-08-23
VANGUARD BREAST MRI AUXILIARY TABLE WITH 8CHSENTINELLE MEDICAL2013-06-04
SENSE NV16 1.5TINVIVO CORPORATION2013-05-01
8CH SHOULDER COIL 1, 5T IRFINVIVO CORP.2013-04-16
*COIL, MAGNETIC RESONANCE, SPECIALTYSIEMENS MEDICAL SOLUTIONS USA, INC2013-02-20

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