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
Oct 25, 2016K162145vRad PACS with Mammography
Virtual Radiologic Corporation
LLZ
Oct 21, 2016K162474Artemis
Eigen
LLZ
Oct 18, 2016K162025IntelliSpace Portal Platform
Philips Medical Systems Nederlands B.V., NL
LLZ
Oct 14, 2016K162011MedDream
Softneta Uab, LT
LLZ
Oct 14, 2016K160371NovaPACS
Novarad Corporation
LLZ
Oct 6, 2016K161109iSR'obot MRI-US Fusion
Biobot Surgical Pte., Ltd., SG
LLZ
Oct 5, 2016K160666Dentiq3D
3D Industrial Imaging Co., Ltd., KR
LLZ
Oct 3, 2016K161828kneeEOS
Onefit Medical, FR
LLZ
Sep 21, 2016K162339Scenium
Siemens Medical Solutions USA, Inc.
LLZ
Sep 21, 2016K162112CAAS MRV
Pie Medical Imaging BV, NL
LLZ
Sep 19, 2016K161625PixelShine
Algomedica
LLZ
Sep 16, 2016K162008JiveX
Visus Technology Transfer GmbH, DE
LLZ
Sep 2, 2016K162141Restore PACS
Xian Wingspan Electronic Technology Co., Ltd., CN
LLZ
Sep 2, 2016K153705PROcedure Rehearsal Studio
3Dsystems, Simbionix Products, IL
LLZ
Aug 24, 2016K161130ResolutionMD
Calgary Scientific, Inc., CA
LLZ
Aug 17, 2016K161518PACS CORE/ENCORE
Compania Mexicana DE Radiologia Cgr, S.A. DE C.V., MX
LLZ
Aug 17, 2016K152949WebPAX
Heart Imaging Technologies, LLC
LLZ
Aug 10, 2016K1619555D Viewer
Samsung Medison Co., Ltd., KR
LLZ
Aug 9, 2016K161148icobrain
Icometrix, BE
LLZ
Aug 5, 2016K161113QXLink
Vieworks Co., Ltd., KR
LLZ
Aug 3, 2016K160284JointPoint
Jointpoint, Inc.
LLZ
Aug 1, 2016K160937Senolris
GE Healthcare, DE
LLZ
Jul 28, 2016K161382LVivo Software Application
Diacardio, Ltd., IL
LLZ
Jul 28, 2016K161118SIMPLANT Online Case Review and SIMPLANT Editor
Dentsply Sirona
LLZ
Jul 13, 2016K161419Multi Modality Viewer
Vital Images, Inc.
LLZ
Jul 11, 2016K161685syngo®.via protoNeo (Version VA10A)
Siemens Healthcare GmbH, DE
LLZ
Jun 28, 2016K161479hipEOS
Onefit Medical, FR
LLZ
Jun 28, 2016K160584Surgical Navigation Advanced Platform (SNAP)
Surgical Theater, LLC
LLZ
Jun 23, 2016K161559Kuvia3D
4qimaging, LLC Dba Qmetrics
LLZ
Jun 22, 2016K161061IMPAX Volume Viewing 4.0
Agfa Healthcare N.V., BE
LLZ
Jun 21, 2016K161444DBSWIN and VistaEasy Imaging Software
Duerr Dental AG, DE
LLZ
Jun 21, 2016K160334Advanced Medical Imaging Software Suite (KSWVWR)
Keosys Sas, FR
LLZ
Jun 17, 2016K153351Quantib Brain 1
Quantib B.V., NL
LLZ
Jun 9, 2016K161188HEPATIQ 1.1
Hepatiq, LLC
LLZ
May 31, 2016K161246Ez3D-i / E3
Ewoosoft Co., Ltd., KR
LLZ
May 27, 2016K1537363mensio Workstation
Pie Medical Imaging BV, NL
LLZ
May 13, 2016K161117EzDent-i / E2 / Prora View
Ewoosoft Co., Ltd., KR
LLZ
Apr 25, 2016K151913MIM-Thin Client (mobile)
Mim Software, Inc.
LLZ
Apr 22, 2016K160914sterEOS Workstation
Eos Imaging, Inc., FR
LLZ
Apr 13, 2016K153653DICOM Viewer
Brainlab AG, DE
LLZ
Apr 12, 2016K160376EndoSize
Therenva Sas, FR
LLZ
Apr 8, 2016K160579Xmaru View V1 and Xmaru PACS, Medical Image Processing Software
Rayence Co., Ltd., KR
LLZ
Apr 8, 2016K160407spineEOS
Onefit Medical, FR
LLZ
Mar 29, 2016K153284Synaptive ImageDrive Pro
Synaptive Medical, Inc., CA
LLZ
Mar 24, 2016K152716EV Insite System
Psp Corporation, JP
LLZ
Mar 16, 2016K160150Vitrea CT Colon Analysis
Vital Images, Inc.
LLZ
Mar 16, 2016K153355Xeleris 4.0 Processing and Review Workstation
GE Healthcare, IL
LLZ
Mar 15, 2016K153612ArthrexVIP Web Portal
Custom Orthopaedic Solutions, Inc.
LLZ
Mar 4, 2016K160426syngo.via MI Workflows
Siemens Medical Solutions USA, Inc.
LLZ
Mar 4, 2016K153346syngo Application Software VD11
Siemens Medical Solutions USA, Inc.
LLZ

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