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Medical equipment and related accessories, software and consumables
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Bioimaging and radiotherapy instruments
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Diagnostic and interventional radiology instruments
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Instruments for extraoral dental radiology
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Instruments for extraoral dental radiology - hardware accessories
Instruments for extraoral dental radiology - hardware accessories
Z11030380
25 devices
Devices
Planmeca Lumo
Planmeca Oy
·
,
FI
Class I
CE/MDR
KaVo ProXam 2D
Planmeca Oy
·
,
FI
Class IIb
CE/MDR
FI23/00000059
Active
Valid to Jun 2030
Scan Ceph
Carestream Dental LLC
·
,
US
Class IIa
CE/MDR
GUDID
on market
Planmeca Viso 2D Classic
Planmeca Oy
·
,
FI
Class IIb
CE/MDR
FI23/00000059
Active
Valid to Jun 2030
Scan Ceph
Carestream Dental LLC
·
,
US
Class IIa
CE/MDR
GUDID
on market
Planmeca ProMax 3D
Planmeca Oy
·
,
FI
Class IIb
CE/MDR
FI23/00000059
Active
Valid to Jun 2030
CE/MDD
+1
authorizations
Planmeca Viso G1
Planmeca Oy
·
,
FI
Class IIb
CE/MDR
FI23/00000059
Active
Valid to Jun 2030
Planmeca Viso G5
Planmeca Oy
·
,
FI
Class IIb
CE/MDR
FI23/00000059
Active
Valid to Jun 2030
GUDID
on market
KaVo ProXam 3DQ
Planmeca Oy
·
,
FI
Class IIb
CE/MDR
FI23/00000059
Active
Valid to Jun 2030
KaVo ProXam 2D Pro
Planmeca Oy
·
,
FI
Class IIb
CE/MDR
FI23/00000059
Active
Valid to Jun 2030
KaVo ProXam 3D
Planmeca Oy
·
,
FI
Class IIb
CE/MDR
FI23/00000059
Active
Valid to Jun 2030
Scan Ceph
Carestream Dental LLC
·
,
US
Class IIa
CE/MDR
GUDID
on market
Scan Ceph
Carestream Dental LLC
·
,
US
Class IIa
CE/MDR
GUDID
on market
Planmeca Olo
Planmeca Oy
·
,
FI
Class I
CE/MDR
Planmeca Viso G7
Planmeca Oy
·
,
FI
Class IIb
CE/MDR
FI23/00000059
Active
Valid to Jun 2030
GUDID
on market
Planmeca ProMax 3D Plus
Planmeca Oy
·
,
FI
Class IIb
FDA 510(k)
K060328
Active
Cleared 15 Mar 2006
CE/MDR
+1
authorizations
Planmeca ProMax
Planmeca Oy
·
,
FI
Class IIb
CE/MDR
FI23/00000059
Active
Valid to Jun 2030
GUDID
on market
Planmeca Viso 2D Pro
Planmeca Oy
·
,
FI
Class IIb
CE/MDR
FI23/00000059
Active
Valid to Jun 2030
FDA 510(k)
K181576
Active
Cleared 13 Sep 2018
+1
authorizations
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