Skip to content
devi
CERTS
Devices
Categories
Manufacturers
Importers
Certifiers
Authorities
Reps.
Representatives
Categories
/
Medical equipment and related accessories, software and consumables
/
Bioimaging and radiotherapy instruments
/
Diagnostic and interventional radiology instruments
/
Mammography systems
Mammography systems
Z110302
101 devices
Subcategories
6
Z11030201
Conventional mammography systems
10
devices
Z11030202
Digital mammography systems
45
devices
Z11030280
Mammography systems - hardware accessories
26
devices
›
Z11030282
Mammography systems - software accessories
8
devices
Z11030285
Mammography systems - consumables
0
devices
Z11030292
Mammography systems - medical device software
12
devices
Devices
Fdr-2000BPY
Fujifilm Corporation
·
,
Japan
Class I
CE/MDR
Pristina Serena
GE Medical Systems SCS
·
,
France
Class IIb
CE/MDR
GUDID
on market
88000168
Shanghai United Imaging Healthcare Co., Ltd.
·
,
China
Class IIb
CE/MDR
898Y101490
Fujifilm Corporation
·
,
Japan
Class I
CE/MDR
401Y120038
Fujifilm Corporation
·
,
Japan
Class I
CE/MDR
MammoScreen
Therapixel SA
·
,
France
Class IIa
FDA 510(k)
K192854
Active
Cleared 25 Mar 2020
CE/MDD
Vara MG
MX Healthcare GmbH
·
,
Germany
Class IIb
CE/MDR
Transpara
ScreenPoint Medical
·
,
Netherlands
Class IIb
CE/MDR
GUDID
on market
Transpara
ScreenPoint Medical
·
,
Netherlands
Class IIa
CE/MDD
GUDID
on market
Transpara
ScreenPoint Medical
·
,
Netherlands
Class IIb
CE/MDR
GUDID
on market
88000075
Shanghai United Imaging Healthcare Co., Ltd.
·
,
China
Class IIa
CE/MDD
CadOne
Three Palm Software
·
,
United States
Class I
CE/MDR
EyeRad
G-Squared SRL
·
,
Italy
Class IIa
CE/MDR
Transpara
ScreenPoint Medical
·
,
Netherlands
Class IIb
CE/MDR
GUDID
on market
Mammo Image Analysis Software
Shanghai United Imaging Intelligence Co., Ltd.
·
,
China
Class IIa
CE/MDR
Vara MG
MX Healthcare GmbH
·
,
Germany
Class IIb
CE/MDR
Transpara
ScreenPoint Medical
·
,
Netherlands
Class IIa
CE/MDD
GUDID
on market
Previous
Next