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Medical equipment and related accessories, software and consumables
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Bioimaging and radiotherapy instruments
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Magnetic resonance imaging (MRI) instruments
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Magnetic resonance (mr) systems
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Magnetic resonance (mr) systems - hardware accessories
Magnetic resonance (mr) systems - hardware accessories
Z11050180
232 devices
Subcategories
3
Z1105018001
Magnetic resonance (mr) radiofrequency surface coils
157
devices
Z1105018002
Magnetic resonance (mr) radiofrequency volumetric coils
19
devices
Z1105018099
Magnetic resonance (mr) systems - hardware accessories - other
56
devices
Devices
Medial Plug VT
Dunlee
·
,
Netherlands
Class IIa
CE/MDR
2243595CE03
Expiring
Valid to Apr 2027
GUDID
on market
16Ch Interface Box Breast Coil Sen 3T
Dunlee
·
,
Netherlands
Class IIa
CE/MDR
2243595CE03
Expiring
Valid to Apr 2027
GUDID
on market
16 Breast Coil
Philips Medical Systems Nederland B.V.
·
,
Netherlands
Class IIa
CE/MDR
2243595CE03
Expiring
Valid to Apr 2027
FDA 510(k)
K233348
Active
Cleared 24 Oct 2023
+1
authorizations
1.5T HD T/R Knee Coil (flat base)
Philips Medical Systems Nederland B.V.
·
,
Netherlands
Class IIa
CE/MDR
GUDID
on market
Lateral Array Coil Left VG STR
Philips Medical Systems Nederland B.V.
·
,
Netherlands
Class IIa
CE/MDR
GUDID
on market
DS Base 3.0T
Philips Medical Systems Nederland B.V.
·
,
Netherlands
Class IIa
CE/MDR
2243595CE02
Expiring
Valid to Apr 2027
GUDID
on market
3Ch Left Coil Element Sen 3T
Dunlee
·
,
Netherlands
Class IIa
CE/MDR
2243595CE03
Expiring
Valid to Apr 2027
GUDID
on market
Lateral Single Loop Coil Left VG GE450
Philips Medical Systems Nederland B.V.
·
,
Netherlands
Class IIa
CE/MDR
GUDID
on market
dS Breast 7ch 3.0T
Philips Medical Systems Nederland B.V.
·
,
Netherlands
Class IIa
CE/MDR
2243595CE02
Expiring
Valid to Apr 2027
GUDID
on market
Head Coil
Esaote S.p.A.
·
,
Italy
Class I
CE/MDR
Endorectal MRI Coil for 3.0T MR Imaging of the Prostate (eCoil®)
Dxtx Medical Inc
·
,
United States
Class IIa
CE/MDD
GUDID
on market
3.0T Ingenia Endorectal Coil Interface Device System (eCoil®)
Dxtx Medical Inc
·
,
United States
Class IIa
CE/MDR
GUDID
on market
Cervical Coil N.14
Esaote S.p.A.
·
,
Italy
Class I
CE/MDR
GUDID
on market
Endorectal MRI Coil for 1.5T MR Imaging of the Prostate (eCoil®)
Dxtx Medical Inc
·
,
United States
Class IIa
CE/MDD
GUDID
on market
Lumbar Coil N.17
Esaote S.p.A.
·
,
Italy
Class I
CE/MDR
GUDID
on market
Smart Fit Knee 3.0T
Philips Healthcare (Suzhou) Co., Ltd.
·
,
China
Class IIa
FDA 510(k)
K233600
Active
Cleared 5 Feb 2024
CE/MDR
+1
authorizations
Discovery Mr 450- 1.5T Split Head Coil
GE Medical Systems, LLC
·
,
United States
Class IIa
CE/MDR
GUDID
on market
Endorectal MRI Coil II for 3.0T MR Imaging of the Prostate (e2CoilTM) – Siemens
Dxtx Medical Inc
·
,
United States
Class I
CE/MDR
Discovery MR750 - 3.0T Split Head Coil
Open recall
GE Medical Systems, LLC
·
,
United States
Class IIa
FDA 510(k)
×4
K083147
Active
Cleared 4 Nov 2008
CE/MDR
+1
authorizations
Head Coil N.16
Esaote S.p.A.
·
,
Italy
Class I
CE/MDR
GUDID
on market
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