System, Image Processing, Radiological

FDA product code LLZ · 2150 cleared devices

Class 2 Radiology

Regulation: 21 CFR 892.2050
Review panel: RA
Implant: No
Life sustaining: No
Third party review: Yes
GMP exempt: No
Clearance span: 1983-12-08 – 2026-09-23

LLZ 2016-02-25

MedicVOD System

Applicant Orpheus Medical , Ltd.

K number K151737

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LLZ 2016-02-23

FS-PACS

Applicant Ec-Web Co., Ltd.

K number K152034

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LLZ 2016-02-19

I4 (Integrated Intelligent Imaging Informatics) system

Applicant Philips Medical Systems Nederland B.V.

K number K160315

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LLZ 2016-02-18

DBSWIN and VistaEasy Imaging Software

Applicant Durr Dental AG

K number K143290

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LLZ 2016-02-17

CliniscanSM MRI

Applicant Picofemto, LLC

K number K153593

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LLZ 2016-02-12

TraumaCad Mobile Release 2.0

Applicant Voyant Health, Ltd.

K number K160001

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LLZ 2016-02-12

CARESTREAM Vue PACS

Applicant Carestream Health, Inc.

K number K153103

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LLZ 2016-02-03

Synapse PACS

Applicant Fujifilm Medical Systems U.S.A, Inc.

K number K160108

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LLZ 2016-01-25

Fusion Bx

Applicant Focal Healtcare, Inc.

K number K153166

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LLZ 2016-01-25

DG PACS

Applicant Dicom Grid, Inc.

K number K152977

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LLZ 2016-01-20

Stereo 3D option for Vision Applications

Applicant GE Medical Systems SCS

K number K152352

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LLZ 2016-01-15

HEALTHMYNE

Applicant Healthmyne, Inc.

K number K153289

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LLZ 2016-01-15

BR-ABVS Viewer 1.0

Applicant Taihao Medical, Inc.

K number K151075

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LLZ 2016-01-12

ImplantMax Software

Applicant Saturn Imaging, Inc.

K number K151152

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LLZ 2016-01-07

Volpara Imaging Software

Applicant Matakina Technology, Ltd.

K number K153427

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LLZ 2016-01-03

Ez3D Plus

Applicant Ewoosoft Co., Ltd.

K number K152746

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LLZ 2013-12-26

OLEA SPHERE

Applicant Olea Medical

K number K132095

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LLZ 2013-12-24

INTUITION - TDA, TVA, PARAMETRIC MAPPING

Applicant Terarecon,Inc.

K number K131447

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LLZ 2013-12-20

ORTHOVIS PREOPERATIVE PLAN

Applicant Custom Orthopaedic Solutions

K number K133367

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LLZ 2013-12-20

XVWEB

Applicant Apteryx, Inc.

K number K132342

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LLZ 2013-12-19

21.3 INCH(54 CM) MONOCHROME LCD MONITOR MS25I2(ML21025)

Applicant Jvckenwood Corporation

K number K133511

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LLZ 2013-12-16

FUSIONSYNC, CHIMAERA FUSIONSYNC

Applicant Chimaera GmbH

K number K132963

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LLZ 2013-12-11

SIDEXIS 4

Applicant Sirona Dental Systems GmbH

K number K132773

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LLZ 2013-12-09

SYNGO.PLAZA VB10A

Applicant Siemens AG Healthcare

K number K132532

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LLZ 2013-12-03

21.3 INCH (54 CM) COLOR LCD MONITOR CCL358I2 (CL21358)

Applicant Jvckenwood Corporation

K number K133185

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LLZ 2013-12-03

21.3 INCH (54 CM) COLOR LCD MONITOR CCL258I2 (CL21258)

Applicant Jvckenwood Corporation

K number K133181

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LLZ 2013-12-03

M-VU BREAST DENSITY

Applicant Vucomp, Inc.

K number K132742

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LLZ 2013-11-27

JUSHA-M52C MEDICAL DISPLAY

Applicant Nanjing Jusha Display Technology Co., Ltd.

K number K131390

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LLZ 2013-11-25

CHARRUAPACS SYSTEM

Applicant Charruasoft SA

K number K133357

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LLZ 2013-11-25

TOMTEC-ARENA 1.0, TOMTEC-ARENA 3D ECHO, CARDIO-ARENA

Applicant Tomtec Imaging Systems GmbH

K number K132544

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LLZ 2013-11-07

CLARISO PACS

Applicant Clariso, Inc.

K number K132799

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LLZ 2013-10-31

PAXERAPACS

Applicant Paxeramed

K number K132586

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LLZ 2013-10-30

MULTIVIEW

Applicant Hologic, Inc.

K number K132316

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LLZ 2013-10-25

MAMMOGRAPHY VIEWER SMV658

Applicant Fujifilm Medical System U.S.A., Inc.

K number K132188

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LLZ 2013-10-17

DYONICS PLAN HIP IMPINGEMENT PLANNING SYSTEM

Applicant Smith & Nephew, Inc.

K number K132636

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LLZ 2013-10-04

ISCHEMA VIEW RAPID

Applicant Ischemaview, Inc.

K number K121447

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LLZ 2013-10-03

AMCAD-UT DETECTION MODEL 2.0

Applicant Lin & Associates, LLC

K number K122536

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LLZ 2013-09-25

NDOHD HIGH DEFINITION IMAGING SYSTEM (NDOHD)

Applicant MethodSense, Inc.

K number K131873

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LLZ 2013-09-24

GE ECHOPAC

Applicant Ge Vingmed Ultrasound AS

K number K131685

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LLZ 2013-09-17

CENTRICITY UNIVERSAL VIEWER ZERO FOOTPRINT CLIENT

Applicant GE Healthcare

K number K131977

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LLZ 2013-09-12

QXLINK

Applicant Vieworks Co., Ltd.

K number K132302

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LLZ 2013-09-06

JUSHA-C31 MEDICAL DISPLAY

Applicant Nanjing Jusha Display Technology Co., Ltd.

K number K131389

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LLZ 2013-09-05

KOSTEC MEDICAL GRADE LDC MONITORS

Applicant Kostec Co., Ltd.

K number K123944

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LLZ 2013-09-04

5MP GRAYSCALE LCD DISPLAY

Applicant Shenzhen Beacon Display Technology Co., Ltd.

K number K132610

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LLZ 2013-08-29

MD242C2 24 DIAGNOSTIC IMAGING LCD MONITOR

Applicant Ned Display Solutions , Ltd.

K number K132587

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LLZ 2013-08-29

EZ3D-I, E3

Applicant Ewoosoft Co., Ltd.

K number K131616

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LLZ 2013-08-29

EZDENTI-I; E2; PRORA VIEW

Applicant Ewoosoft Co., Ltd.

K number K131594

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LLZ 2013-08-29

OMNI-VUE 2 SYSTEM

Applicant Genesis Digital Imaging, Inc.

K number K130374

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LLZ 2013-08-29

MAVEN PRO

Applicant Nsequence

K number K130242

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LLZ 2013-08-21

JUSHA-M32 MEDICAL DISPLAY

Applicant Nanjing Jusha Display Technology Co., Ltd.

K number K131391

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LLZ 2013-08-21

CORVIEW

Applicant Marrek, Inc.

K number K131158

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LLZ 2013-08-20

SYNGO.MR GENERAL; SYNGO.MR CARDIOLOGY; SYNGO.MR VASCULAR

Applicant Siemens Medical Solutions USA, Inc.

K number K130749

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LLZ 2013-08-15

ORTHOVISION

Applicant Ewoosoft Co., Ltd.

K number K131570

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LLZ 2013-08-15

LVIVO EF SYSTEM

Applicant Diacardio, Ltd.

K number K130779

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LLZ 2013-08-09

QLAB QUANTIFICATION SOFTWARE

Applicant Philips Ultrasound, Inc.

K number K132165

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LLZ 2013-08-06

THE KINEGRAPH VMA (VERTEBRAL MOTION ANALYZER) SOFTWARE VERSION 2.0; THE MOTION NORMALIZER PATIENT HANDLING AND DATA COLL

Applicant Ortho Kinematics, Inc.

K number K130743

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LLZ 2013-07-26

3D PROSTATE SUITE 3DTRUS PROSTATE MAPPING, MRI/3DTRUS FUSION OPTION, SECOND LOOK 3DTRUS FUSION OPTION

Applicant Koelis

K number K131448

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LLZ 2013-07-25

IQQA-LIVER MULTIMODALITY SOFTWARE

Applicant Edda Technology, Inc.

K number K131498

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LLZ 2013-07-23

ESIE APPS SUITE

Applicant Siemens Medical Solutions USA, Inc.

K number K132062

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LLZ 2013-07-23

ULTRAEXTEND USWS-900A V2.1 AND V3.1

Applicant Toshiba America Medical Systems, In.C

K number K131822

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LLZ 2013-07-18

21.3 INCH MONOCHROME DIGITAL MAMMOGRAPHY LCD MONITOR MS55I2 (ML21055, MD211G5)

Applicant Jvckenwood Corporation

K number K131137

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LLZ 2013-07-12

MIPLATFORM MEDICAL IMAGING SUITE

Applicant Hinacom Software and Technology, Ltd.

K number K131424

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LLZ 2013-07-03

2MP COLOR LCD MONITOR, RADIFORCE MX215

Applicant Eizo Corporation

K number K131090

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LLZ 2013-06-28

CODIAGNOSTIX IMPLANT PLANNING SOFTWARE

Applicant Straumann USA

K number K130724

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LLZ 2013-06-14

SYNAPSE 3D LUNG AND ABDOMEN ANALYSIS

Applicant Fujifilm Medical System U.S.A., Inc.

K number K130542

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LLZ 2013-05-29

ETIAM PACS COMPONENTS

Applicant Etiam S.A.S.U.

K number K131392

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LLZ 2013-05-29

NIO COLOR 3MP LED

Applicant Barco N.V.

K number K131295

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LLZ 2013-05-29

MR PERMEABILITY

Applicant Philips Medical Systems Nederland B.V.

K number K130278

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LLZ 2013-05-24

CORONIS 3MP

Applicant Barco N.V.

K number K131246

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LLZ 2013-05-22

ANYTHINK PACS WORKSTATION

Applicant Beijing Crealife Technology Co., Ltd.

K number K131299

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LLZ 2013-05-20

NORDIC TUMOREX

Applicant Nordicneurolab

K number K123306

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LLZ 2013-05-17

THE VAULT SYSTEM

Applicant Somersault Orthopedics, Inc.

K number K124051

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LLZ 2013-05-16

4D VIEW

Applicant GE Healthcare

K number K131118

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LLZ 2013-05-16

MOBILECT VIEWER

Applicant Nephosity, Inc.

K number K123082

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LLZ 2013-05-13

QLAB QUANTIFICATION SOFTWARE HEART MODEL

Applicant Philips Health Care

K number K130159

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LLZ 2013-05-07

CONI

Applicant Globalmed

K number K130624

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LLZ 2013-04-18

MD211C2 21.3 DIAGNOSTIC IMAGING LCD MONITOR

Applicant Nec Display Solutions , Ltd.

K number K130772

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LLZ 2013-04-18

MD211C3 21.3 DIAGNOSTIC IMAGING LCD MONITOR

Applicant Nec Display Solutions , Ltd.

K number K130770

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LLZ 2013-04-12

ZMED VP4000

Applicant Zmed, Inc.

K number K130929

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LLZ 2013-04-12

XELERIS 3.1 PROCESSING AND REVIEW WORKSTATION

Applicant Ge Medical Systems F.I. Haifa

K number K130884

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LLZ 2013-04-09

SYNAPSE 3D CARDIAC TOOLS

Applicant Fujifilm Medical System U.S.A., Inc.

K number K130383

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LLZ 2013-04-05

INNOVA EPVISION 2.0, INNOVA EPVISION 2.0

Applicant GE Healthcare

K number K130069

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LLZ 2013-04-02

INTUITION

Applicant Terarecon,Inc.

K number K121916

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LLZ 2013-03-28

5MP MONOCHROME LCD MONITOR, RADIFORCE GX540

Applicant Eizo Nanao Corporation

K number K130336

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LLZ 2013-03-26

NOBELCLINICIAN

Applicant Nobel Biocare AB

K number K123976

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LLZ 2013-03-20

MIRADA RTX

Applicant Mirada Medical, Ltd.

K number K130393

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LLZ 2013-03-20

SUITEHEART

Applicant Neosoft, LLC

K number K130228

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LLZ 2013-03-14

RESOLUTIONMD MOBILE 3.1 MODEL RMD-MOB-31

Applicant Calgary Scientific, Inc.

K number K123186

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LLZ 2013-03-11

STEREOS WORKSTATION

Applicant Eos Imaging, Inc.

K number K130395

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LLZ 2013-03-01

MEDICVOD, MEDICAST, MEDISHOW, MEDISEARCH, CENTRAL STORAGE SYSTEM - CSS

Applicant Orpheus Medical , Ltd.

K number K123426

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LLZ 2013-02-25

VITREA CT TRANSCATHETER AORTIC VALVE REPLACMENT (TAVR) PLANNING

Applicant Vital Images, Inc.

K number K122578

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LLZ 2013-02-20

ARIX RAD ACQUISITION CONSOLE

Applicant Compania Mexicana DE Radiologia Cgr, S.A. DE C.V.

K number K123650

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LLZ 2013-02-19

MAMMOWORKSTATION

Applicant Image Diagnost International GmbH

K number K123575

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LLZ 2013-02-19

COMMUNIFY PACS VIEWER

Applicant Communify Health, LLC

K number K120851

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LLZ 2013-02-08

CORONIS FUSION 6MP

Applicant Barco N.V.

K number K130103

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LLZ 2013-02-08

4MP COLOR LCD MONITOR, RADIFORCE RX440

Applicant Eizo Nanao Corporation

K number K130070

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LLZ 2013-02-08

SURGERY REHEARSAL PLATFORM

Applicant Surgical Theater, LLC

K number K123023

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LLZ 2013-02-06

CAAS INTRAVASCULAR

Applicant Pie Medical Imaging BV

K number K123970

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LLZ 2013-02-01

INVIVO DENTAL

Applicant Anatomage, Inc.

K number K123519

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LLZ 2013-02-01

SYNGO, BREAST CARE

Applicant Siemens Medical Solutions USA, Inc.

K number K123420

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