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
Feb 15, 2019K182332PhantomMSK
OrthoGrid Systems, Inc.
LLZ
Feb 14, 2019K190074Presero 3D Scanning System
Certis Health
LLZ
Feb 1, 2019K183272AI Rad Companion (Engine)
Siemens Medical Solutions USA, Inc.
LLZ
Jan 9, 2019K183133MRCP+ v1.0
Perspectum Diagnostics, Ltd., GB
LLZ
Jan 2, 2019K182855ProKnow DS
Proknow, LLC
LLZ
Dec 28, 2018K180867AmCAD-UO
Amcad Biomed Corporation, TW
LLZ
Dec 27, 2018K182564Quantib ND
Quantib B.V., NL
LLZ
Dec 27, 2018K182130iSchemaView RAPID
Ischemaview, Inc.
LLZ
Dec 21, 2018K183012vascuCAP
Elucid Bioimaging, Inc.
LLZ
Dec 21, 2018K1827504D View
GE Medical Systems Ultrasound and Primary Care Diagnostics
LLZ
Dec 20, 2018K1730413DIEMME RealGUIDE
3Diemme , Ltd., IT
LLZ
Dec 18, 2018K182624MIM - MRT Dosimetry
Mim Software, Inc.
LLZ
Dec 14, 2018K182601Vitrea Software Package, VSTP-001A
Canon Medical Systems Corporation, JP
LLZ
Dec 14, 2018K182419Centricity Universal Viewer
GE Healthcare
LLZ
Dec 13, 2018K182359HipCheck
Stryker Corp.
LLZ
Dec 6, 2018K182926IntelliSpace Radiology
Philips Healthcare Informatics, Inc.
LLZ
Dec 6, 2018K182016Simplicit90Y
Mirada Medical, Ltd., GB
LLZ
Dec 4, 2018K181825CAAS MR Solutions
Pie Medical Imaging BV, NL
LLZ
Dec 3, 2018K173083IMPLANTER DENTAL PLANNING SOFTWARE
Implanter, LLC
LLZ
Nov 30, 2018K182815XVWeb 3D
Apteryx, Inc.
LLZ
Nov 26, 2018K183038Corin Optimized Positioning System (OPS) Plan
Corin USA
LLZ
Nov 26, 2018K183013Vitrea Software Package, VSTP-001A
Canon Medical Systems Corporation, JP
LLZ
Nov 26, 2018K182431Konicaminolta DI-X1
Konica Minolta, Inc., JP
LLZ
Nov 21, 2018K173744ProFuse CAD
Eigen
LLZ
Nov 20, 2018K181247Vitrea CT Brain Perfusion
Vital Images, Inc.
LLZ
Nov 7, 2018K173001uWS-CT
Shanghai United Imaging Healthcare Co., Ltd., CN
LLZ
Nov 7, 2018K172999uWS-MR
Shanghai United Imaging Healthcare Co., Ltd., CN
LLZ
Nov 6, 2018K181939icobrain
Icometrix NV, BE
LLZ
Oct 31, 2018K171199AVIEW
Coreline Soft Co., Ltd., KR
LLZ
Oct 26, 2018K173965Implant Planning Software
Inteware Co., Ltd., CN
LLZ
Oct 25, 2018K182464PeekMed
Peek Health, S.A., PT
LLZ
Oct 23, 2018K181964JiveX
Visus Health IT GmbH, DE
LLZ
Oct 19, 2018K182561UroNav (Version 3.0)
Invivo Corporation
LLZ
Oct 17, 2018K182034Arterys MICA
Arterys, Inc.
LLZ
Oct 11, 2018K181460OnePacs System
Onepacs, LLC
LLZ
Oct 9, 2018K181892Ziostation2
Ziosoft, Inc., JP
LLZ
Sep 25, 2018K182290IBM iConnect Access
Merge Healthcare Incorporated
LLZ
Sep 25, 2018K181773Synapse 3D Optional Tools
Fujifilm Corporation, JP
LLZ
Sep 24, 2018K180916iNtuition-T1 Mapping and T2/T2* Mapping
Terarecon,Inc.
LLZ
Sep 21, 2018K182310Volpara Imaging Software
Volpara Health Technologies Limited, NZ
LLZ
Sep 21, 2018K181926InVivo Web Viewer
Anatomage, Inc.
LLZ
Sep 21, 2018K172418OpenSight
Novarad Corporation
LLZ
Sep 7, 2018K182230Multi Modality Viewer
Vital Images, Inc.
LLZ
Sep 7, 2018K182208syngo.via View&GO (Version VA10A)
Siemens Healthcare GmbH, DE
LLZ
Sep 7, 2018K170702mediCAD 4.0
Medicad Hectec GmbH, DE
LLZ
Aug 31, 2018K180006AmCAD-UT Detection 2.2
Amcad Biomed Corporation, TW
LLZ
Aug 29, 2018K181185Change Healthcare Enterprise Viewer
Change Healthcare Canada Company, CA
LLZ
Aug 16, 2018K180522IGTFusion
Igi Technologies
LLZ
Aug 13, 2018K181318ONIS-PACS
Digitalcore Co., Ltd., JP
LLZ
Aug 7, 2018K181962CubeVue
Curvebeam, LLC
LLZ

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