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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
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Magnetic resonance (mr) radiofrequency surface coils
Magnetic resonance (mr) radiofrequency surface coils
Z1105018001
157 devices
1.5T Hd Shoulder Array
GE Healthcare Coils
·
,
United States
Class I
CE/MDR
GUDID
on market
3.0T Hd 8CH Cardiac Array
GE Healthcare Coils
·
,
United States
Class I
CE/MDR
GUDID
on market
5” Round Coil 1.5T
GE Medical Systems, LLC
·
,
United States
Class I
CE/MDR
GUDID
on market
3.0T Air Mp M
GE Healthcare Coils
·
,
United States
Class I
FDA 510(k)
K182504
Active
Cleared 12 Oct 2018
CE/MDR
+1
authorizations
3.0T Air Mp L
GE Healthcare Coils
·
,
United States
Class I
CE/MDR
GUDID
on market
3.0T Laa
GE Healthcare Coils
·
,
United States
Class I
CE/MDR
GUDID
on market
1.5T 12 Channel Body Array
GE Healthcare Coils
·
,
United States
Class I
CE/MDR
GUDID
on market
32Ch AIR Open Coil Suite, 1.5T
Neocoil, LLC
·
,
United States
Class I
FDA 510(k)
K213687
Active
Cleared 11 Mar 2022
CE/MDR
+1
authorizations
1.5T 16ch Breast Coil
Neocoil, LLC
·
,
United States
Class I
FDA 510(k)
×2
K222407
Active
Cleared 14 Oct 2022
CE/MDR
+1
authorizations
3T Receive-Only 16ch Flex SPEEDER Medium
Neocoil, LLC
·
,
United States
Class I
FDA 510(k)
K141832
Active
Cleared 31 Jul 2014
CE/MDR
+1
authorizations
1.5T HD 8Ch Shoulder Coil
Neocoil, LLC
·
,
United States
Class I
CE/MDR
GUDID
on market
3.0T AIR Open Neck Chest Anterior 7ch
Neocoil, LLC
·
,
United States
Class I
CE/MDR
GUDID
on market
GEM Flex Coil 16-L Array, 1.5T Receive Only
Neocoil, LLC
·
,
United States
Class I
FDA 510(k)
K252179
Active
Cleared 10 Feb 2026
CE/MDR
+1
authorizations
3.0T HD 8Ch Shoulder Coil
Neocoil, LLC
·
,
United States
Class I
CE/MDR
GUDID
on market
3” Round Coil 1.5T
Ge Medical Systems, Inc.
·
,
United States
Class I
CE/MDR
GUDID
on market
dS NVS Spine Coil 1.5T
Philips Healthcare (Suzhou) Co., Ltd.
·
,
China
Class IIb
CE/MDR
dS NVS Head Base Coil 1.5T
Philips Healthcare (Suzhou) Co., Ltd.
·
,
China
Class IIb
CE/MDR
3.0T Hd Breast Array
GE Healthcare Coils
·
,
United States
Class I
CE/MDR
GUDID
on market
dS Flex Coil L 1.5T
Philips Healthcare (Suzhou) Co., Ltd.
·
,
China
Class IIb
CE/MDR
1.5T 16ch AIR AA
GE Healthcare Coils
·
,
United States
Class I
CE/MDR
GUDID
on market
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