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 2011-12-17

8MP COLOR LCD MONITOR,RADIFORCE RX840

Applicant Eizo Nanao Corporation

K number K113226

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LLZ 2011-12-16

ONDEMAND3D

Applicant Cybermed, Inc.

K number K113543

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LLZ 2011-12-16

CLEARSTART SVM SYSTEM

Applicant Intio, Inc.

K number K113541

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LLZ 2011-12-13

VIEW 1 IMAGING

Applicant Karl Storz Endoscopy America, Inc.

K number K112480

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LLZ 2011-12-06

DENTAL 3D PLANNING SOFTWARE

Applicant Symbyo Dental, LLC

K number K113404

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LLZ 2011-12-02

MOBILE MIM

Applicant Mim Software, Inc.

K number K112930

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LLZ 2011-11-30

CENTRICITY CARDIO IMAGING

Applicant Ge Healthcare Integrated IT Solutions

K number K112570

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LLZ 2011-11-30

5MP MONOCHROME LCD MONITOR, RADIFORCE GX530

Applicant Eizo Nanao Corporation

K number K112354

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LLZ 2011-11-18

SYNGO VIA MI WORKFLOWS

Applicant Siemens Medical Solutions USA, Inc.

K number K113029

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LLZ 2011-11-18

VITREA CT MYOCARDIAL ANALYSIS

Applicant Vital Images, Inc.

K number K112531

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LLZ 2011-11-18

ONCO TRAC MODEL 1, 2, 4

Applicant Translational Sciences Corporation

K number K111642

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LLZ 2011-11-18

MW100 (MAMMOGRAPHY) LCD MONITOR SYSTEM

Applicant Wide Corporation

K number K110596

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LLZ 2011-11-07

MONOCHROME DIGITAL MAMMOGRAPHY LCD MONITOR MS33I2

Applicant Totoku Electric Co., Ltd.

K number K112145

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LLZ 2011-11-04

PERFSCAPE V2.0

Applicant Olea Medical

K number K111161

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LLZ 2011-11-04

FXA (TM)

Applicant Aces GmbH

K number K110765

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LLZ 2011-11-01

UC-CARE NAVIGO SYTEM

Applicant UC-CARE , Ltd.

K number K100784

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LLZ 2011-10-27

21.3 INCH (54 CM) COLOR LCD MONITOR CCL356I2 (CL21356)

Applicant Totoku Electric Co., Ltd.

K number K112604

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LLZ 2011-10-27

4MP COLOR LCD MONITOR, RADIFORCERX430

Applicant Eizo Nanao Corporation

K number K112466

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LLZ 2011-10-20

PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM

Applicant Curve Dental, Inc.

K number K112974

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LLZ 2011-10-20

CARESTREAM PACS

Applicant Carestream Health, Inc.

K number K110919

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LLZ 2011-10-17

SYNAPSE WORKSTATION SOFTWARE VERSION 3.3.0

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

K number K112439

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LLZ 2011-10-17

CORONIS 5MP

Applicant Barco N.V.

K number K111990

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LLZ 2011-10-12

LUNGPOINT PLANNING AND VIRTUAL BRONCHOSCOPIC NAVIGATION (VBN) SOFTWARE

Applicant Broncus Technologies, Inc.

K number K112051

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LLZ 2011-09-30

3DI INCLUDING CSCORE

Applicant Shina Systems , Ltd.

K number K112530

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LLZ 2011-09-30

IMAGELINK

Applicant Computer Programs and Systems, Inc.

K number K112096

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LLZ 2011-09-30

SURGIMAP (TM) SPINE

Applicant Nemaris, Inc.

K number K111019

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LLZ 2011-09-26

SURGICASE ORTHOGNATHIC SOFTWARE WIZARD

Applicant Materialise NV

K number K111641

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LLZ 2011-09-26

21.3 INCH (54CM) MONOCHROME DIGITAL MAMMOGRAPHY LCD MONITOR

Applicant Totoku Electric Co., Ltd.

K number K111496

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LLZ 2011-09-22

CORONIS FUSION 4MP DL

Applicant Barco N.V.

K number K111989

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LLZ 2011-09-21

VIRTUE

Applicant Diagnosoft, Inc.

K number K111833

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LLZ 2011-09-15

MOLECULAR BREAST IMAGING SOFTWARE

Applicant Gamma Medica-Ideas Incorporated

K number K111731

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LLZ 2011-09-15

ASTRA

Applicant Candelis, Inc.

K number K111694

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LLZ 2011-09-15

FEEL-DRCS

Applicant Imfou Co., Ltd.

K number K110033

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LLZ 2011-09-15

R4 ACERT ULTRASOUND REPORTING SYSTEM

Applicant R4, LLC

K number K101898

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LLZ 2011-09-13

XELIS CARDIAC

Applicant Infinitt Co., Ltd.

K number K111660

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LLZ 2011-09-09

RESOLUTIONMD MOBILE MODEL RMB-MOB-2X

Applicant Calgary Scientific, Inc.

K number K111346

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LLZ 2011-09-08

XELIS FUSION

Applicant Infinitt Co., Ltd.

K number K111613

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LLZ 2011-08-29

AIDA HD CONNECT WITH SMARTSCREEN / BLU-RAY DRIVE / SMARTSCREEN WITH BLU-RAY DRIVE

Applicant KARL STORZ Endoscopy-America, Inc.

K number K103308

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LLZ 2011-08-26

ZENIS, PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM

Applicant Genoray Co., Ltd.

K number K103181

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LLZ 2011-08-23

CT42 CARDIAC COMPUTED TOMOGRAPHY (CT) SOFTWARE

Applicant Circle Cardiovascular Imaging, Inc.

K number K111373

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LLZ 2011-08-11

NIO COLOR 2MP

Applicant Barco N.V.

K number K111991

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LLZ 2011-08-10

RADIOLOGICAL IMAGE PROCESSING SYSTEM

Applicant VATECH Co., Ltd.

K number K102078

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LLZ 2011-08-05

IMPAX NEXT GENERATION

Applicant Agfa Healthcare N.V.

K number K111945

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LLZ 2011-08-05

IBIS EXPLORER AND MARKUP SOFTWARE

Applicant Medqia

K number K111319

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LLZ 2011-07-29

HEARTNAVIGATOR RELEASE 1

Applicant Philips Medical Systems Nederland B.V.

K number K111245

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LLZ 2011-07-28

VITREAVIEW SOFTWARE 6.1

Applicant Vital Images, Inc.

K number K111892

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LLZ 2011-07-28

INTELLISPACE PACS 4.X

Applicant Philips Healthcare Informatics, Inc.

K number K111804

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LLZ 2011-07-28

MRI-Q SYSTEM

Applicant Resonance Health Analysis Services Pty, Ltd.

K number K111222

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LLZ 2011-07-28

XELIS 3D

Applicant Infinitt Co., Ltd.

K number K103130

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LLZ 2011-07-20

COMMUNIFY PACS VIEWER

Applicant Flying Squirrel Storage, LLC

K number K110797

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LLZ 2011-07-01

SIMPLANT 2011

Applicant Materialise Dental NV

K number K110300

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LLZ 2011-06-30

CLIO/CLIOSOFT

Applicant Sota Precision Optics, Inc.

K number K110886

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LLZ 2011-06-24

IMPAX VOLUME VIEWING

Applicant Agfa Healthcare N.V.

K number K111638

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LLZ 2011-06-21

QLAB 8.1 QUANTIFICATION SOFTWARE

Applicant Philips Ultrasound, Inc.

K number K110414

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LLZ 2011-06-15

MD301C4 29.8 DIAGNOSTIC IMAGING LCD MONITOR, L309TY

Applicant Nec Display Solutions , Ltd.

K number K111237

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LLZ 2011-06-08

10 MP GRAYSCALE FLAT PANEL DISPLAY (GX 1030)

Applicant Eizo GmbH

K number K103724

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LLZ 2011-05-27

ECHOINSIGHT

Applicant Ultrasound Medical Devices, Inc.

K number K110447

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LLZ 2011-05-24

EBW NM 2.0

Applicant Philips Medical Systems (Cleveland), Inc.

K number K111336

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LLZ 2011-05-24

AZE VIRTUALPLACE-MR FLOW ANALYSIS SOFTWARE

Applicant Aze, Ltd.

K number K102534

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LLZ 2011-05-20

SYNGO NEURO PBV-IR

Applicant Siemens Medical Solutions USA, Inc.

K number K111052

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LLZ 2011-05-20

SICAT IMPLANT V1.2

Applicant Sicat GmbH & Co. KG

K number K103723

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LLZ 2011-05-13

SYNGO.VIA WEB VIEWER

Applicant Siemens AG Medical Solutions

K number K111079

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LLZ 2011-05-11

DOLPHIN IMAGING

Applicant Patterson Dental Supply, Inc.

K number K110430

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LLZ 2011-05-06

EUNITY

Applicant Client Outlook, Inc.

K number K111164

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LLZ 2011-05-05

RADIOVISION

Applicant Haas Software

K number K111102

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LLZ 2011-05-05

CENTRICITY PACS

Applicant GE Healthcare

K number K110875

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LLZ 2011-05-03

READY VIEW

Applicant Ge Healthcare (Ge Medical Systems Scs)

K number K110573

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LLZ 2011-04-26

AW VOLUMESHARE 5 WITH ANGIOVIZ OPTION

Applicant GE Healthcare

K number K110834

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LLZ 2011-04-21

JETPACK 2.0

Applicant Philips Medical Systems (Cleveland), Inc.

K number K111024

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LLZ 2011-04-21

CURVE IMAGE

Applicant Curve Dental, Inc.

K number K110139

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LLZ 2011-04-20

SYMBIA.NET

Applicant Siemens Medical Solutions USA, Inc.

K number K110844

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LLZ 2011-04-12

MEDVOXEL HEARTPRO SOFTWARE APPLICATION

Applicant Medvoxel Systems, Inc.

K number K103565

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LLZ 2011-04-08

IMAGE-ARENA AND IMAGE-ARENA APPLICATIONS

Applicant Tomtec Imaging Systems GmbH

K number K110667

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LLZ 2011-04-07

4D SONO-SCAN 1.0

Applicant Tomtec Imaging Systems GmbH

K number K110595

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LLZ 2011-04-07

SYNAPSE 3D LIVER ANALYSIS

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

K number K110186

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LLZ 2011-04-06

SYNGO MBF

Applicant Siemens Medical Solutions USA, Inc.

K number K110494

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LLZ 2011-03-24

CLEARCANVAS RIS / PACS

Applicant Clearcanvas, Inc.

K number K110332

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LLZ 2011-03-17

AYCAN WORKSTATION OSIRIX PRO

Applicant Aycan Digitalsysteme GmbH

K number K103546

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LLZ 2011-03-16

MODALIXX

Applicant Ampronix, Inc.

K number K110108

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LLZ 2011-03-16

SYNAPSE 3D LUNG AND ABDOMEN ANALYSIS

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

K number K103720

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LLZ 2011-03-11

E4D COMPASS

Applicant D4D Technologies

K number K110511

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LLZ 2011-03-07

THORACIC VCAR

Applicant Ge Medical Systems, LLC

K number K103480

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LLZ 2011-03-04

BARCO MAMMO TOMOSYNTHESIS

Applicant Barco N.V.

K number K103792

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LLZ 2011-03-04

SYNAPSE 3D CEREBRAL ANALYSIS

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

K number K103687

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LLZ 2011-03-04

VIEWPOINT 6

Applicant GE Healthcare

K number K103458

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LLZ 2011-03-03

AXIS PACS, HMS PACS

Applicant Axis Health Care, LLC

K number K103679

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LLZ 2011-02-18

MIM 5.2 (BRACHY)

Applicant Mim Software, Inc.

K number K103576

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LLZ 2011-02-11

VISUALIZE: VASCULAR

Applicant The Medipattern Corporation

K number K103761

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LLZ 2011-02-04

MOBILE MIM

Applicant Mim Software, Inc.

K number K103785

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LLZ 2011-02-04

ACIES

Applicant Konica Minolta Medical & Graphic, Inc.

K number K101842

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LLZ 2011-02-04

STEREOS WORKSTATION

Applicant Biospace Med

K number K101398

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LLZ 2011-02-02

SECURVIEW DX DIAGNOSTIC WORKSTATION

Applicant Hologic, Inc.

K number K103385

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LLZ 2011-01-31

COR ANALYZER

Applicant Rcadia Medical Imaging , Ltd.

K number K110071

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LLZ 2011-01-31

SYNAPSE 3D CARDIAC TOOLS

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

K number K103465

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LLZ 2011-01-28

NEUCOLONCARE

Applicant Neusoft Medical Systems Co., Ltd.

K number K110077

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LLZ 2011-01-26

OMNIVISION

Applicant Modern Module, Inc.

K number K110040

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LLZ 2011-01-25

Q-STATION

Applicant Philips Ultrasound, Inc.

K number K103815

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LLZ 2011-01-14

TRIANA, PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM

Applicant Genoray Co., Ltd.

K number K103182

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LLZ 2011-01-05

SPINEANALYER MODEL SAPOC

Applicant Optasia Medical

K number K103475

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LLZ 2010-12-14

SAFECT MODEL VER 1.0

Applicant Medic Vision Brain Technologies, Ltd.

K number K100372

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