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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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Various instruments for radiodiagnostics and interventional procedures
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Fluoroscopy devices
Fluoroscopy devices
Z11039009
42 devices
Devices
Belliger Ace (Arex)
Genoray Co., Ltd.
·
,
KR
Class IIb
FDA 510(k)
K252229
Active
Cleared 2 Apr 2026
CE/MDR
Medical Diagnostic X-Ray Equipment
Zhuhai Perlead Medical Equipment Co., Ltd.
·
,
CN
Class IIb
CE/MDR
OSCAR 15(Unique FD)
Genoray Co., Ltd.
·
,
KR
Class IIb
FDA 510(k)
K172180
Active
Cleared 9 Feb 2018
CE/MDD
+1
authorizations
ProxiDiagnost N90 1.1
Open recall
Philips Medical Systems DMC GmbH
·
,
DE
Class IIb
FDA 510(k)
K212837
Active
Cleared 21 Sep 2021
FDA 510(k)
K173433
Active
Cleared 5 Feb 2018
+2
authorizations
ZEN-2090 Turbo
Genoray Co., Ltd.
·
,
KR
Class IIb
FDA 510(k)
K211780
Active
Cleared 9 Mar 2022
CE/MDR
+1
authorizations
LUMINOS Impulse
Siemens Shanghai, Medical Equipment Ltd.
·
,
CN
Class IIb
CE/MDR
Medical Diagnostic X-Ray Equipment
Zhuhai Perlead Medical Equipment Co., Ltd.
·
,
CN
Class IIb
CE/MDR
Opescope Acteno FD15
Genoray Co., Ltd.
·
,
KR
Class IIb
CE/MDR
OSCAR Prime
Genoray Co., Ltd.
·
,
KR
Class IIb
CE/MDR
GUDID
on market
Phoenix 3000
medi-x Thomas Kadlubowski e.K.
·
,
DE
Class IIb
CE/MDR
Garion
Sg Healthcare Co, Ltd.
·
,
KR
Class IIb
CE/MDR
2026-MDR/QS-026
Active
Valid to May 2031
88001398
Shanghai United Imaging Healthcare Co., Ltd.
·
,
CN
Class IIb
CE/MDR
Unique Class
Genoray Co., Ltd.
·
,
KR
Class IIb
CE/MDR
Medical Diagnostic X-Ray Equipment
Zhuhai Perlead Medical Equipment Co., Ltd.
·
,
CN
Class IIb
CE/MDR
Opescope Acteno FD15
Genoray Co., Ltd.
·
,
KR
Class IIb
CE/MDR
ZEN-2090Pro (ZEN-CX2090 +2 more)
Genoray Co., Ltd.
·
,
KR
Class IIb
CE/MDD
GUDID
on market
Unique FD
Genoray Co., Ltd.
·
,
KR
Class IIb
CE/MDR
Digital Radiography and Fluoroscopy System
Beijing Wandong Medical Technology Co., Ltd.
·
,
CN
Class IIb
CE/MDR
Smart-C
Turner Imaging Systems, Inc.
·
,
US
Class IIb
CE/MDD
GUDID
on market
Garion+
Sg Healthcare Co, Ltd.
·
,
KR
Class IIb
CE/MDR
2026-MDR/QS-026
Active
Valid to May 2031
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