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 5, 2018K173512MFI-Cardiac
Multifunctional Imaging, LLC
LLZ
Jan 31, 2018K173088Vitrea Software Toshiba Package VSTP-001A
Toshibamedical Systems Corporation, JP
LLZ
Jan 25, 2018K173542Arterys Oncology DL
Arterys, Inc.
LLZ
Jan 16, 2018K173622CS Imaging
Trophy, FR
LLZ
Jan 16, 2018K173054Navigo Workstation Version 2.0
UC-CARE , Ltd., IL
LLZ
Jan 12, 2018K173588Illumeo System
Philips Medical Systems Technologies , Ltd., IL
LLZ
Jan 11, 2018K172224DTX Studio diagnose
Nobel Biocare AB, SE
LLZ
Jan 8, 2018K171328cNeuro cMRI
Combinostics OY, FI
LLZ
Jan 5, 2018K173456ViewPoint 6
Ge Medical Systems Ultrasound and Primary
LLZ
Dec 27, 2017K173420Radiomics App v1.0
Microsoft Corp.
LLZ
Dec 12, 2017K173467Advanced Diffusion Analysis (ADA) application
Philips Medical Systems Nederland B.V., NL
LLZ
Dec 8, 2017K173475Merge PACS
Merge Healthcare Incorporated
LLZ
Nov 21, 2017K172218MIM – Y90 Dosimetry
Mim Software, Inc.
LLZ
Nov 20, 2017K173378syngo®.via protoNeo (Version VA20)
Siemens Healthcare GmbH, DE
LLZ
Nov 15, 2017K173329jFit Surgical Planner
Jointvue, LLC
LLZ
Nov 14, 2017K171385Planmeca Romexis
Planmeca Oy, FI
LLZ
Nov 8, 2017K173247Surgical Planning Software version 1.1
Ortho Kinematics, Inc.
LLZ
Oct 27, 2017K172803Infinitt PACS 7.0
Infinitt Healthcare Co., Ltd., KR
LLZ
Oct 26, 2017K173094OrthoVision
Ewoosoft Co., Ltd., KR
LLZ
Oct 20, 2017K171709BR-FHUS Viewer 1.0
Taihao Medical, Inc., TW
LLZ
Oct 20, 2017K163623Quantra
Hologic, Inc.
LLZ
Oct 18, 2017K173101Curve Image 2.0 PACS
Curve Dental, Ltd., CA
LLZ
Oct 18, 2017K171068OrthoView 7.2
Meridian Technique, Ltd., GB
LLZ
Oct 5, 2017K172855Vitrea Advanced Visualization, Version 7.6
Vital Images, Inc.
LLZ
Sep 29, 2017K171463ASPIRE Bellus II
Fujifilm Medical Systems U.S.A, Inc.
LLZ
Sep 26, 2017K170816Elements Image Fusion, Elements Cranial Distortion Correction, Elements Spine Curvature Correction, Elements TRAM
Brainlab AG, DE
LLZ
Sep 14, 2017K1725133D Echo
Jointvue, LLC
LLZ
Sep 7, 2017K170981NeuroQuant
Cortechs Labs, Inc.
LLZ
Aug 25, 2017K172327VMA™ System version 3.0
Ortho Kinematics, Inc.
LLZ
Aug 22, 2017K172364EzDent-i / E2 / Prora View
Ewoosoft Co., Ltd., KR
LLZ
Aug 22, 2017K171617OKI Surgical Planning Software
Ortho Kinematics, Inc.
LLZ
Aug 3, 2017K171356Clarity Reveal
Ceevra, Inc.
LLZ
Jul 28, 2017K171754NovaPACS
Novarad Corporation
LLZ
Jul 28, 2017K163048Smart Stitching Software System, Image Processing, Radiological
Osko, Inc.
LLZ
Jul 26, 2017K170841BiopSee, Mobile US
Medcom GmbH, DE
LLZ
Jul 21, 2017K163232Vitrea View
Vital Images, Inc.
LLZ
Jul 18, 2017K171544Arterys Viewer
Arterys, Inc.
LLZ
Jul 18, 2017K170729Examion X-AQS
Examion GmbH, DE
LLZ
Jul 17, 2017K1711153D Endo Software
Dentsply Sirona
LLZ
Jul 3, 2017K170434Enterprise Imaging XERO Viewer 8.1
Agfa Healthcare N.V., BE
LLZ
Jun 23, 2017K163668SUITESTENSA
Ebit Srl, IT
LLZ
Jun 14, 2017K170847EchoPAC Software Only, EchoPAC Plug-in
GE Medical Systems Ultrasound and Primary Care Diagnostics
LLZ
Jun 9, 2017K170747syngo Application Software
Siemens Medical Solutions USA, Inc.
LLZ
Jun 8, 2017K171222Vitrea Software Toshiba Package; VSTP-001A
Toshibamedical Systems Corporation, JP
LLZ
Jun 7, 2017K170250SmartTarget
Smarttarget, Ltd., GB
LLZ
Jun 1, 2017K171053syngo Dynamics Version VA30
Siemens Healthcare GmbH, DE
LLZ
May 30, 2017K171314QLAB Advanced Quantification Software
Philips Health Care
LLZ
May 30, 2017K162574AmCAD-US
Amcad Biomed Corporation, TW
LLZ
May 24, 2017K170172UNiD Spine Analyzer
Medicrea International, FR
LLZ
May 24, 2017K163071vascuCAP
Elucid Bioimaging, Inc.
LLZ

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