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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
Sep 18, 2014K140399EBM IDO VIEWER
Ebm Technologies USA, LLC
LLZ
Sep 17, 2014K142048EMPRINT PROCEDURE PLANNING APPLICATION
Covidien, LLC
LLZ
Sep 15, 2014K141137STEREOS WORKSTATION
Eos Imaging
LLZ
Sep 3, 2014K141514SYNAPSE 3D TENSOR ANALYSIS
Fujifilm Meidcal Systems U.S.A.,Inc.
LLZ
Aug 29, 2014K141364CLIMB MAMMOGRAPHY VIEWER SOFTWARE
Climb Medical Systems, Inc., JP
LLZ
Aug 26, 2014K141451VixWin Platinum
Imaging Sciences International (Dba Gendex, LLC)
LLZ
Aug 22, 2014K141480CVI42
Circle Cardiovascular Imaging, Inc., CA
LLZ
Aug 5, 2014K131348ORTOMED
Infomed Servicios Informaticos S.L., ES
LLZ
Aug 1, 2014K141302VITREA CT MULTI-CHAMBER CARDIAC FUNCTIONAL ANALYSIS (CFA)
Vital Images, Inc.
LLZ
Aug 1, 2014K141061REMOTEYE VIEWER
Neologica S.R.L., IT
LLZ
Jul 31, 2014K141475ENDOSIZE
Therenva Sas, FR
LLZ
Jul 18, 2014K140897SYNGO.MR NEUROLOGY, SYNGO.MMR GENERAL
Siemens Medical Solutions USA, Inc.
LLZ
Jul 11, 2014K141554ESIE APPS SUITE
Siemens Medical Solutions USA, Inc.
LLZ
Jul 3, 2014K140869DCAS I
Gp&P Co., Ltd.
LLZ
Jul 2, 2014K141556AVREO INTERWORKS SYSTEM
Avreo, Inc.
LLZ
Jul 2, 2014K140909MCKESSON RADIOLOGY
Mckesson Medical Imaging Company
LLZ
Jun 27, 2014K140819SURGICAL NAVIGATION ADVANCED PLATFORM
Surgical Theater, LLC
LLZ
Jun 20, 2014K141329RADSPA
Telerad Tech Private Limited
LLZ
Jun 20, 2014K141199QUENTRY DOSE REVIEW
Brainlab AG, DE
LLZ
Jun 16, 2014K140713PLANMECA ROMEXIS
Planmeca Oy, FI
LLZ
Jun 13, 2014K140960PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM
Hologic, Inc.
LLZ
Jun 13, 2014K133098SENYINT PACS
Dalian Senyint Digital Medical System Co., Ltd.
LLZ
Jun 5, 2014K140434MEDICAD CLASSIC
Hectec GmbH, DE
LLZ
Jun 2, 2014K140337BRIGHTMATTER PLANNING SOFTWARE
Synaptive Medical, Inc., CA
LLZ
May 28, 2014K140139CLEARVIEWHD
Clearview Diagnostics, Inc.
LLZ
May 23, 2014K132684MEDWS SOFTWARE (VARIANTS MEDVIEW, MEDDIAG, MEDMAMMO)
Medecom Sarl, FR
LLZ
May 13, 2014K140395VITREA IMAGE DENOISING SOFTWARE
Vital Images, Inc.
LLZ
Apr 23, 2014K140445DEXIS SOFTWARE: DEXIS IMAGING SUITE, DEXIS MAC
Imaging Sciences International, LLC
LLZ
Apr 17, 2014K140808Q-STATION
Philips Ultrasound, Inc.
LLZ
Apr 11, 2014K133521AZE PHOENIX SOFTWARE
Aze, Ltd., JP
LLZ
Apr 4, 2014K133910NORDICBRAINEX
Nordicneurolab, NO
LLZ
Apr 1, 2014K140271TABLET VIEWER SOFTWARE FOR IMAGE SUITE
Carestream Health, Inc.
LLZ
Mar 28, 2014K133984CORONIS 5MP
Barco N.V., BE
LLZ
Mar 26, 2014K133508RESOLUTIONMD MOBILE
Calgary Scientific, Inc., CA
LLZ
Mar 25, 2014K133663NIO COLOR 2MP
Barco N.V., BE
LLZ
Mar 11, 2014K133401SYNO MR NEUROLOGY, SYNGO MR ONCOLOGY, SYNGO. MR BREVIS, SYNGO MMR GENERAL
Siemens Medical Solutions USA, Inc.
LLZ
Mar 7, 2014K140093TABLE
Anatomage, Inc.
LLZ
Mar 7, 2014K133135IMPAX VOLUME VIEWING 3.0
Agfa Healthcare N.V., BE
LLZ
Mar 6, 2014K133966MODEL-BASED RSA SOFTWARE
Halifax Biomedical, Inc.
LLZ
Mar 6, 2014K133022ZEDVIEW
Lexi Co., Ltd.
LLZ
Mar 3, 2014K133937HEARTSCAN SOFTWARE
Morpheus Imaging, Inc.
LLZ
Feb 28, 2014K133654SCENIUM
Siemens Medical Solutions USA, Inc.
LLZ
Feb 28, 2014K133609THE DOME S6C
Nds Surgical Imaging
LLZ
Feb 28, 2014K132763ADVANCED VIEWER
Brainlab AG, DE
LLZ
Feb 27, 2014K140033TARGET3D FUSION
Convergent Life Sciences, Inc.
LLZ
Feb 26, 2014K133385LUNGPOINT ATV PLANNING AND NAVIGATION SOFTWARE
Broncus Medical, Inc.
LLZ
Feb 25, 2014K133644SYNGO.VIA MI WORKFLOWS
Siemens Medical Solutions USA, Inc.
LLZ
Feb 25, 2014K133320SICAT FUNCTION
Sicat GmbH & Co. KG, DE
LLZ
Feb 19, 2014K14021430.0 INCH COLOR LCD MONITOR CCL650I2 (CL30650, MD302C6)
Jvckenwood Corporation, JP
LLZ
Feb 14, 2014K1401083MP COLOR LCD DISPLAY
Shenzhen Beacon Display Technology Co., Ltd., CN
LLZ

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