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Medical equipment and related accessories, software and consumables
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Bioimaging and radiotherapy instruments
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Integrated MRI/pet systems
Integrated MRI/pet systems
Z110207
37 devices
Subcategories
5
Z11020701
MRI/pet systems
3
devices
Z11020780
Integrated MRI/pet systems - hardware accessories
31
devices
Z11020782
Integrated MRI/pet systems - software accessories
2
devices
Z11020785
Integrated MRI/pet systems - consumables
0
devices
Z11020792
Integrated MRI/pet systems - medical device software
1
device
Devices
Signa Pet/Mr
GE Medical Systems, LLC
·
,
US
Class IIa
CE/MDR
GUDID
on market
88000741
Shanghai United Imaging Healthcare Co., Ltd.
·
,
CN
Class IIa
FDA 510(k)
×4
K183014
Active
Cleared 27 Feb 2019
CE/MDD
+1
authorizations
Signa Pet/Mr
Open recall
GE Medical Systems, LLC
·
,
US
Class IIa
FDA 510(k)
×3
K213709
Active
Cleared 20 Jan 2022
CE/MDR
+1
authorizations
Rft
Shenzhen RF Tech Co., Ltd.
·
,
CN
Class I
CE/MDR
GUDID
on market
SyncBox
Nordicneurolab AS
·
,
NO
Class I
CE/MDR
GUDID
on market
ResponseGrips
Nordicneurolab AS
·
,
NO
Class I
CE/MDR
GUDID
on market
Rft
Shenzhen RF Tech Co., Ltd.
·
,
CN
Class I
CE/MDR
GUDID
on market
Rft
Shenzhen RF Tech Co., Ltd.
·
,
CN
Class I
CE/MDR
GUDID
on market
Rft
Shenzhen RF Tech Co., Ltd.
·
,
CN
Class I
CE/MDR
GUDID
on market
Rft
Shenzhen RF Tech Co., Ltd.
·
,
CN
Class I
CE/MDR
GUDID
on market
Rft
Shenzhen RF Tech Co., Ltd.
·
,
CN
Class I
CE/MDR
Rft
Shenzhen RF Tech Co., Ltd.
·
,
CN
Class I
CE/MDR
GUDID
on market
Rft
Shenzhen RF Tech Co., Ltd.
·
,
CN
Class I
CE/MDR
GUDID
on market
Rft
Shenzhen RF Tech Co., Ltd.
·
,
CN
Class IIa
CE/MDR
CN24/00003794
Active
Valid to Jun 2029
GUDID
on market
Rft
Shenzhen RF Tech Co., Ltd.
·
,
CN
Class I
CE/MDR
GUDID
on market
Rft
Shenzhen RF Tech Co., Ltd.
·
,
CN
Class IIa
CE/MDR
CN24/00003794
Active
Valid to Jun 2029
GUDID
on market
InroomViewingDevice
Nordicneurolab AS
·
,
NO
Class I
CE/MDR
GUDID
on market
Rft
Shenzhen RF Tech Co., Ltd.
·
,
CN
Class I
CE/MDR
GUDID
on market
VisualSystem HD
Nordicneurolab AS
·
,
NO
Class I
CE/MDR
GUDID
on market
Rft
Shenzhen RF Tech Co., Ltd.
·
,
CN
Class I
CE/MDR
GUDID
on market
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