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Medical equipment and related accessories, software and consumables
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Bioimaging and radiotherapy instruments
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Nuclear medicine instruments
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Various instruments for nuclear medicine
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Various instruments for nuclear medicine - medical device software
Various instruments for nuclear medicine - medical device software
Z11029092
19 devices
Devices
PLANET Onco Dose
Dosisoft
·
,
FR
Class IIb
FDA 510(k)
K182966
Active
Cleared 6 Mar 2019
CE/MDR
Hermia
Hermes Medical Solutions AB
·
,
SE
Class IIa
CE/MDR
28620167501
Active
Valid to Oct 2028
Hermia Olinda
Hermes Medical Solutions AB
·
,
SE
Class IIb
CE/MDR
28620167501
Active
Valid to Oct 2028
CSMC Cardiac Suite
Cedars-Sinai Medical Center
·
,
US
Class IIa
FDA 510(k)
K172609
Active
Cleared 3 Nov 2017
CE/MDR
+1
authorizations
PHMCalc
Softway Medical
·
,
FR
Class I
CE/MDD
3D-Rd
Radiopharmaceutical Imaging and Dosimetry, LLC
·
,
US
Class I
CE/MDR
GUDID
on market
Hermia
Hermes Medical Solutions AB
·
,
SE
Class IIa
CE/MDR
28620167501
Active
Valid to Oct 2028
Oasis
Segami Corporation
·
,
US
Class IIa
CE/MDD
GUDID
on market
Qdose
ΒΑΡΩΝΟΣ ΑΓΑΜ. ΚΑΙ ΣΙΑ Ο.Ε. με διακριτικό τίτλο KeV Medical Imaging
·
,
EL
Class IIa
CE/MDR
Hermia
Hermes Medical Solutions AB
·
,
SE
Class IIb
CE/MDR
28620167501
Active
Valid to Oct 2028
GUDID
on market
Nuclarity
nuclivision
·
,
BE
Class IIa
CE/MDR
UniSyn Molecular Imaging
Convergent Imaging Solutions
·
,
CA
Class IIa
CE/MDR
Hermia
Hermes Medical Solutions AB
·
,
SE
Class IIa
CE/MDR
28620167501
Active
Valid to Oct 2028
GUDID
on market
Hermia Multimodality Viewer
Hermes Medical Solutions AB
·
,
SE
Class IIa
CE/MDR
28620167501
Active
Valid to Oct 2028
GUDID
on market
Oasis
Segami Corporation
·
,
US
Class IIa
CE/MDD
GUDID
on market
Hermia
Hermes Medical Solutions AB
·
,
SE
Class IIa
CE/MDD
GUDID
on market
Venus Calc
NICESOFT - Segami
·
,
FR
Class I
CE/MDD
Hermia
Hermes Medical Solutions AB
·
,
SE
Class IIb
CE/MDR
28620167501
Active
Valid to Oct 2028
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