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Results for “IMS GIOTTO”
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EUDAMED
17
FDA 510(k)
2
FDA PMA
GUDID
12
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European Union (all)
16
United States
14
More countries (6)
Italy
5
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4
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3
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2
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1
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1
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Class I
12
Class IIa
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14
More classes (11)
Class A
4
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IVD General
IVD Annex II List A
IVD Annex II List B
IVD for self-testing
Active implantable (AIMDD)
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30 devices found
·
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Device · Manufacturer · Authorizations
Verified
Status
Regime
Registry
Class
Giotto Class 3D
Ims Giotto SpA
·
,
FDA registration: United States
Class II
GUDID
on market
None
GUDID
II
Giotto Image 3DL
Ims Giotto SpA
·
,
FDA registration: United States
Class II
GUDID
on market
None
GUDID
II
Giotto Class S Ready
Ims Giotto SpA
·
,
FDA registration: United States
Class II
GUDID
on market
None
GUDID
II
Giotto Class S 2D
Ims Giotto SpA
·
,
FDA registration: United States
Class II
GUDID
on market
None
GUDID
II
Giotto Class S 3D
Ims Giotto SpA
·
,
FDA registration: United States
Class II
GUDID
on market
None
GUDID
II
Giotto Image 3DL/3MP
Ims Giotto SpA
·
,
FDA registration: United States
Class II
GUDID
on market
None
GUDID
II
Biopsy Digit Sl
Ims Giotto SpA
·
,
FDA registration: United States
Class II
GUDID
on market
None
GUDID
II
Giotto Image M
Ims Giotto SpA
·
,
FDA registration: United States
Class II
GUDID
on market
None
GUDID
II
Giotto Class (Models - 3000X-YY and 4000X-YY)
Ims Giotto S.P.A.
·
,
Italy
Class II
CE/IVDR
CE/MDR
+1
authorizations
Active
CE MDR
CE IVDR
510(k)
510(k)
II
Smart Finder
Ims Giotto S.P.A.
·
,
Italy
Class II
FDA 510(k)
K203509
Active
Cleared 14 Jul 2021
Active
510(k)
510(k)
II
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