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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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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
Pristina Duo
GE Medical Systems SCS
·
,
France
Class IIb
CE/MDR
Harmonia B
MEDICAL TECHNOLOGIES Ltd
·
,
Russia
Class IIb
CE/MDR
Helianthus Dbt
Metaltronica SpA
·
,
Italy
Class IIb
CE/MDR
Hestia
Genoray Co., Ltd.
·
,
South Korea
Class IIb
FDA 510(k)
K243420
Active
Cleared 17 Jul 2025
CE/MDR
+1
authorizations
88000752
Shanghai United Imaging Healthcare Co., Ltd.
·
,
China
Class IIb
CE/MDR
Helianthus C
Metaltronica SpA
·
,
Italy
Class IIb
FDA 510(k)
K202822
Active
Cleared 15 Dec 2021
CE/MDR
Mammography
Sino Medical-Device Technology Co., Ltd
·
,
China
Class IIb
CE/MDR
88000777
Shanghai United Imaging Healthcare Co., Ltd.
·
,
China
Class IIb
CE/MDR
Mammography
Sino Medical-Device Technology Co., Ltd
·
,
China
Class IIb
CE/MDR
Dmx-600
Genoray Co., Ltd.
·
,
South Korea
Class IIb
CE/MDR
80506485
Shanghai United Imaging Healthcare Co., Ltd.
·
,
China
Class IIb
CE/MDD
Helianthus
Metaltronica SpA
·
,
Italy
Class IIb
CE/MDR
GUDID
on market
Harmonia DBT
MEDICAL TECHNOLOGIES Ltd
·
,
Russia
Class IIb
CE/MDR
Aidia
Drtech Corp.
·
,
South Korea
Class IIb
CE/MDR
CE/MDD
Digital Mammography X-ray system
Bemems Co., Ltd.
·
,
South Korea
Class IIb
CE/MDD
Mammography
Sino Medical-Device Technology Co., Ltd
·
,
China
Class IIb
CE/MDD
Planmed Clarity+
Planmed Oy
·
,
Finland
Class IIb
CE/MDR
FI23/0000004
Active
Valid to Aug 2029
Digital Mammography System
Drtech Corp.
·
,
South Korea
Class IIb
CE/MDR
88000751
Shanghai United Imaging Healthcare Co., Ltd.
·
,
China
Class IIb
CE/MDR
Harmonia C
MEDICAL TECHNOLOGIES Ltd
·
,
Russia
Class IIb
CE/MDR
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