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)
Get daily alerts for LLZSample briefCSV

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
Aug 3, 2018K171435VirtuOst Vertebral Fracture Assessment
O.N. Diagnostics, LLC
LLZ
Aug 2, 2018K171977miPlatform medical imaging suite v3.0 (miPlatform v3.0), miPlatform ZFP Viewer
Hinacom Software and Technology, Ltd., CN
LLZ
Jul 23, 2018K173444Quantitative Total Extensible Imaging (QTxI)
Aiq Solutions, Inc.
LLZ
Jul 19, 2018K180629DentiqGuide
3D Industrial Imaging Co., Ltd., KR
LLZ
Jul 10, 2018K173274Ceevra Reveal 2.0
Ceevra, Inc.
LLZ
Jun 26, 2018K173574DenSeeMammo
Statlife, FR
LLZ
Jun 22, 2018K180815MIM - SPECTRA Quant
Mim Software, Inc.
LLZ
Jun 19, 2018K172346sterEOS Workstation
Eos Imaging, FR
LLZ
Jun 15, 2018K181290Fusion Bx 2.0
Focal Healthcare, Inc., CA
LLZ
Jun 14, 2018K173780EchoMD Automated Ejection Fraction Software
Bay Labs, Inc.
LLZ
Jun 7, 2018K181264QLAB Advanced Quantification Software
Philips Ultrasound, Inc.
LLZ
May 31, 2018K181177Interventional Workspot
Philips Medical Systems Nederland B.V., NL
LLZ
May 24, 2018K181080McKesson Cardiology
Change Healthcare Israel , Ltd., IL
LLZ
May 15, 2018K1808835D Viewer
Samsung Medison Co., Ltd., KR
LLZ
May 4, 2018K180641Invenia ABUS Viewer
GE Healthcare
LLZ
Apr 27, 2018K173390hipEOS
Onefit Medical, FR
LLZ
Apr 25, 2018K180563syngo.plaza
Siemens Healthcare GmbH, DE
LLZ
Apr 24, 2018K172768ZOOM
Zetta Medical Technologies, LLC
LLZ
Apr 20, 2018K180161Viz CTP
Viz. Ai, Inc.
LLZ
Apr 19, 2018K180336syngo.MR Applications
Siemens Medical Solutions USA, Inc.
LLZ
Apr 19, 2018K172477iSchemaView RAPID
Ischemaview, Inc.
LLZ
Apr 12, 2018K180549ZED Link
Zed Technologies, AU
LLZ
Apr 5, 2018K180125PowerLook Density Assessment Software
Icad, Inc.
LLZ
Apr 5, 2018K173897syngo.via MI Workflows
Siemens Medical Solutions USA, Inc.
LLZ
Apr 5, 2018K172998uWS-MI
Shanghai United Imaging Healthcare Co., Ltd., CN
LLZ
Apr 5, 2018K171847Corin Optimized Positioning System (OPS™) Plan
Corin U.S.A. Limited
LLZ
Apr 4, 2018K173597Scenium VE20 Software
Siemens Medical Solutions USA, Inc.
LLZ
Apr 4, 2018K172239SIMPLANT 18
Dentsply Sirona
LLZ
Mar 30, 2018K180323Vitrea Software Package; VSTP-001A
Canon Medical Systems Corporation, JP
LLZ
Mar 23, 2018K173241MED-TAB
Plum Medical Solutions GmbH, DE
LLZ
Mar 21, 2018K180192Emprint Ablation Visualization Application
Covidien, LLC
LLZ
Mar 21, 2018K173619Mimics inPrint
Materialise NV, BE
LLZ
Mar 21, 2018K172168WillCeph
Hdx Will Corp., KR
LLZ
Mar 16, 2018K180129Imbio Segmentation Editing Tool software
Imbio, LLC
LLZ
Mar 16, 2018K173611syngo Application Software
Siemens Medical Solutions USA, Inc.
LLZ
Mar 12, 2018K180262SICAT Endo
Sicat GmbH & Co. KG, DE
LLZ
Mar 9, 2018K180394BrightMatter Plan 1.6.0
Synaptive Medical, Inc., CA
LLZ
Mar 9, 2018K173939Quantib Brain
Quantib B.V., NL
LLZ
Mar 8, 2018K180326icobrain
Icometrix, BE
LLZ
Mar 8, 2018K173605iQMR
Medic Vision - Imaging Solutions, Ltd., IL
LLZ
Mar 2, 2018K173312ProBx Software
Harmonus, Inc.
LLZ
Feb 28, 2018K173145CereMetrix Silver
Ceremetrix Corp
LLZ
Feb 23, 2018K173863Ez3D-i /E3
Ewoosoft Co., Ltd., KR
LLZ
Feb 23, 2018K170540DM-Density
Densitas, Inc., CA
LLZ
Feb 15, 2018K173636Velocity
Varian Medical Systems, Inc.
LLZ
Feb 12, 2018K170793SuRgical Planner (SRP)
Surgical Theater, LLC
LLZ
Feb 8, 2018K180091UNiD Spine Analyzer
Medicrea International, FR
LLZ
Feb 8, 2018K162727SENYINT Remote Consultation System
Dalian Senyint Digital Medical System Co., Ltd., CN
LLZ
Feb 6, 2018K172832Insight BD
Siemens Medi Cal Solutions, Inc.
LLZ
Feb 6, 2018K172490eUnity
Client Outlook, Inc., CA
LLZ

Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.