ClearanceBrief
Panels › Radiology › Product code LLZ · Class 2

System, Image Processing, Radiological

Regulation 892.2050

48510(k)s in 12 months (2,295 all time)
25recalls in 12 months (562 all time)
544recalls that name a 510(k)
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Top companies in LLZ

Company510(k)sRecalls
Siemens AG Medical Solutions9589
GE Healthcare2384
Merge Healthcare Incorporated661
Carestream Health, Inc.953
Vital Images, Inc.3410
Agfa Corp.634
Totoku Electric Co., Ltd.400
Barco N.V.370
Eizo Nanao Corporation340
Ewoosoft Co., Ltd.290
Decided510(k)Device and applicantCode
May 21, 2020K200274CariCloud
Caristo Diagnostics, GB
LLZ
May 18, 2020K201062syngo Ultrasound Apps Suite (sUSAS)
Siemens Medical Solutions USA, Inc.
LLZ
May 5, 2020K200546ZeeroMED View
O3 Enterprise Srl, IT
LLZ
May 5, 2020K200315Ziostation2
Ziosoft, Inc., JP
LLZ
May 5, 2020K193220AVIEW LCS
Coreline Soft Co., Ltd., KR
LLZ
May 1, 2020K192656Optimized Positioning System (OPS) Insight
Corin USA
LLZ
Apr 30, 2020K193523ArthrexVIP Web Portal
Arthrex, Inc.
LLZ
Apr 23, 2020K192475NemoFAB
Software Nemotec S.L., ES
LLZ
Apr 14, 2020K200703JiveX
Visus Health IT GmbH, DE
LLZ
Apr 14, 2020K193369Xelis Dental 2.0
Infinitt Healthcare Co., Ltd., KR
LLZ
Apr 10, 2020K200078VARO Plan
3D Industrial Imaging Co., Ltd., KR
LLZ
Apr 9, 2020K200713EchoNavigator
Philips Medical Systems Nederland B.V., NL
LLZ
Apr 2, 2020K192176IntelePACS
Intelerad Medical Systems Incorporated, CA
LLZ
Mar 16, 2020K190767AnatomicAligner
The Methodist Hospital Research Institute D/B/A Houston
LLZ
Mar 13, 2020K192888EzOrtho
Ewoosoft Co., Ltd., KR
LLZ
Mar 5, 2020K190993Kinepict Medical Imaging Tool version v2.2
Kinepict Health, Ltd., HU
LLZ
Feb 28, 2020K192962icobrain-ctp
Icometrix NV, BE
LLZ
Feb 25, 2020K200178Ez3D-i /E3
Ewoosoft Co., Ltd., KR
LLZ
Feb 19, 2020K192973densitas densityai
Densitas, Inc., CA
LLZ
Feb 18, 2020K200179Collaboration Live
Philips Health Care
LLZ
Feb 18, 2020K200132Ashvins
Medicalcommunications GmbH, DE
LLZ
Feb 14, 2020K192923Vitrea Software Package
Canon Medical Systems Corporation, JP
LLZ
Feb 14, 2020K192372ASCEND Image Viewer
Ascend Hit
LLZ
Feb 13, 2020K193498Infinitt RT PACS
Infinitt Healthcare Co., Ltd., KR
LLZ
Feb 11, 2020K192165Acteon Imaging Suite
De Gotzen S.R.L., IT
LLZ
Jan 31, 2020K192462syngo.MR Applications
Siemens Medical Solutions USA, Inc.
LLZ
Jan 24, 2020K193261FlightPlan for Embolization
GE Medical Systems SCS, FR
LLZ
Jan 23, 2020K191014Elements Viewer
Brainlab AG, DE
LLZ
Jan 20, 2020K192098EzMobile
Ewoosoft Co., Ltd., KR
LLZ
Jan 15, 2020K191125ADAS 3D
Galgo Medical S.L, ES
LLZ
Jan 6, 2020K192917ViewPoint 6
Ge Medical Systems Ultrasound And
LLZ
Dec 31, 2019K192912AutoMIStar
Apollo Medical Imaging Technology Pty. , Ltd., AU
LLZ
Dec 27, 2019K193403UroNav System
Invivo Corporation
LLZ
Dec 27, 2019K193149True 3D Viewer Software
Echopixel, Inc.
LLZ
Dec 20, 2019K192040AVIEW Modeler
Coreline Soft Co., Ltd., KR
LLZ
Dec 19, 2019K183676DentiqAir
3D Industrial Imaging Co., Ltd., KR
LLZ
Dec 13, 2019K192531QyScore Software
Qynapse, FR
LLZ
Dec 13, 2019K192130Icobrain
Icometrix NV, BE
LLZ
Dec 11, 2019K192571NemoScan
Software Nemotec S.L., ES
LLZ
Dec 7, 2019K192279PhantomMSK Trauma
OrthoGrid Systems, Inc.
LLZ
Dec 4, 2019K192348SICAT Implant V2.0
Sicat GmbH & Co. KG, DE
LLZ
Dec 2, 2019K192038Emprint Visualization Application
Covidien, LLC
LLZ
Nov 22, 2019K192508Medsynapse Ris Pacs & Medsynapse VNA
Medsynaptic Private, Ltd., IN
LLZ
Nov 19, 2019K191278RSI-MRI+
Multimodal Imaging Services Corporation (Dba Healthlytix)
LLZ
Nov 8, 2019K191959QuantX Breast MRI Biopsy Guidance Plugin
Qlarity Imaging
LLZ
Nov 7, 2019K191026MEDIP PRO
Medical IP Co., Ltd., KR
LLZ
Nov 5, 2019K192109KOALA
Ib Lab GmbH, AT
LLZ
Nov 5, 2019K190868Cleerly Labs
Cleerly, Inc.
LLZ
Oct 31, 2019K192743VisionX 2.4
Durr Dental SE, DE
LLZ
Oct 31, 2019K183412mediCAD Web
Medicad Hectec GmbH, DE
LLZ

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