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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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Radiology instruments
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Radiology instruments - software accessories
Radiology instruments - software accessories
Z11030582
48 devices
Devices
SpineQ
Bonescreen GmbH
·
,
DE
Class IIa
CE/MDR
Z-24-007-S-E
Active
Valid to Jun 2030
Radiological Image Processing System
Jpi Healthcare. Co., Ltd.
·
,
KR
Class IIa
FDA 510(k)
K213057
Active
Cleared 18 Feb 2022
CE/MDR
+1
authorizations
mint Lesion
Mint Medical GmbH
·
,
DE
Class IIb
CE/MDR
GUDID
on market
Annalise Container
Harrison-Ai Medical Pty Ltd
·
,
AU
Class IIb
CE/MDR
RBfracture
Radiobotics ApS
·
,
DK
Class IIa
CE/MDR
UT-Station
Shimadzu Corporation
·
,
JP
Class IIa
CE/MDD
Methinks Stroke Suite
Methinks Software SL
·
,
ES
Class IIb
CE/MDR
RevealAI-Lung™
Precision Medical Ventures Inc.
·
,
US
Class IIa
FDA 510(k)
K251769
Active
Cleared 30 Jan 2026
CE/MDD
SubtleMR (Software as a Service for post-processing of Magnetic Resonance data)
Subtle Medical, Inc.
·
,
US
Class IIa
CE/MDR
28620157147
Active
Valid to Jul 2028
FDA 510(k)
K191688
Active
Cleared 16 Sep 2019
+2
authorizations
OmegaAI Image Viewer
Ramsoft Inc
·
,
CA
Class I
FDA 510(k)
K222476
Active
Cleared 17 Nov 2022
CE/MDD
+1
authorizations
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