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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 volumetric coils
Magnetic resonance (mr) radiofrequency volumetric coils
Z1105018002
19 devices
Devices
Head Coil
Esaote S.p.A.
·
,
IT
Class I
CE/MDR
Endorectal MRI Coil for 3.0T MR Imaging of the Prostate (eCoil®)
Dxtx Medical Inc
·
,
US
Class IIa
CE/MDD
GUDID
on market
3.0T Ingenia Endorectal Coil Interface Device System (eCoil®)
Dxtx Medical Inc
·
,
US
Class IIa
CE/MDR
GUDID
on market
Cervical Coil N.14
Esaote S.p.A.
·
,
IT
Class I
CE/MDR
GUDID
on market
Endorectal MRI Coil for 1.5T MR Imaging of the Prostate (eCoil®)
Dxtx Medical Inc
·
,
US
Class IIa
CE/MDD
GUDID
on market
Lumbar Coil N.17
Esaote S.p.A.
·
,
IT
Class I
CE/MDR
GUDID
on market
Smart Fit Knee 3.0T
Philips Healthcare (Suzhou) Co., Ltd.
·
,
CN
Class IIa
FDA 510(k)
K233600
Active
Cleared 5 Feb 2024
CE/MDR
Discovery Mr 450- 1.5T Split Head Coil
GE Medical Systems, LLC
·
,
US
Class IIa
CE/MDR
GUDID
on market
Endorectal MRI Coil II for 3.0T MR Imaging of the Prostate (e2CoilTM) – Siemens
Dxtx Medical Inc
·
,
US
Class I
CE/MDR
Discovery MR750 - 3.0T Split Head Coil
Open recall
GE Medical Systems, LLC
·
,
US
Class IIa
FDA 510(k)
K083147
Active
Cleared 4 Nov 2008
FDA 510(k)
K163331
Active
Cleared 17 Mar 2017
+4
authorizations
Head Coil N.16
Esaote S.p.A.
·
,
IT
Class I
CE/MDR
GUDID
on market
Cervical Coil N.9
Esaote S.p.A.
·
,
IT
Class I
CE/MDR
Lumbar Coil N.18
Esaote S.p.A.
·
,
IT
Class I
CE/MDR
GUDID
on market
Xl Spine Coil 10
Esaote S.p.A.
·
,
IT
Class I
CE/MDR
GUDID
on market
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