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 2003-10-02

ECHOENCODER

Applicant Icardiogram, Incorporated

K number K032324

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LLZ 2003-10-02

SECTRA ORTHOPEDIC PACKAGE

Applicant Sectra-Imtec AB

K number K031590

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LLZ 2003-10-02

3D INVIVO BY CSIST

Applicant Chung-Shan Institute of Science and Technology

K number K031567

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LLZ 2003-09-25

RATTAN IMACS BY RATTAN INFORMATION CORPORATION

Applicant Rattan Information Corporation

K number K032176

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LLZ 2003-09-24

TELEMIS-MEDICAL SOLUTION

Applicant Telemis S.A.

K number K032157

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LLZ 2003-09-17

APAX PACS SYSTEM

Applicant Tis, Inc.

K number K032760

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LLZ 2003-09-11

DOME CX DIGITAL FLAT-PANEL DISPLAY SYSTEM MODEL, C3 COLOR AND C3 GRAY

Applicant Planar Systems, Inc.

K number K032638

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LLZ 2003-09-02

51CM(20.1INCH) TFT MONOCHROME LCD MONITOR, MU5111BW

Applicant Iiyama Corporation

K number K032020

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LLZ 2003-08-27

LCD MONITOR, RADIFORCE G11, G31, G51

Applicant Eizo Nanao Corporation

K number K032026

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LLZ 2003-08-22

VIATRONIX V3D EXPLORER, REVISION 1.2

Applicant Viatronix, Inc.

K number K032483

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LLZ 2003-08-14

ORTHOVIEW

Applicant Omsbar, Ltd.

K number K032401

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LLZ 2003-08-14

PHILIPS FRESCO RELEASE 1

Applicant Philips Medical Systems North America Co.

K number K031836

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LLZ 2003-08-14

DVNET MDV-PACS

Applicant Dvnet International Technology Co., Ltd.

K number K031816

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LLZ 2003-08-11

RAMSOFT PACS, MODEL 3.0

Applicant Ramsoft, Inc.

K number K031562

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LLZ 2003-08-07

PRACTICEBUILDER 1-2-3

Applicant Erad Imagemedical Corp.

K number K031778

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LLZ 2003-08-06

CADSTREAM

Applicant Confirma, Inc.

K number K031779

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LLZ 2003-08-01

DOME CX DIGITAL FLAT-PANEL DISPLAY SYSTEM, MODELS C2 AND C5I

Applicant Planar Systems, Inc.

K number K032202

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LLZ 2003-07-31

FILMLESS CLINIC

Applicant Connect Imaging, Inc.

K number K031704

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LLZ 2003-07-24

WIDE 3MP GRAYSCALE TFT LCD MONITOR IF2103A

Applicant Wide Corporation

K number K032174

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LLZ 2003-07-21

CARDIO VASCULAR INFORMATION ENHANCED WORKSTATION

Applicant Electromed Imaging, Inc.

K number K031638

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LLZ 2003-07-18

PHILIPS VIEWFORUM 2003

Applicant Philips Medical Systems

K number K032096

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LLZ 2003-07-08

5MP TFT LCD MONITOR SYSTEM IF2105A BY WIDE CORPORATION

Applicant Wide Corporation

K number K031929

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LLZ 2003-07-02

PERSONAL DIGITAL WORKSTATION (PDW); FILM DIGITIZING CAMERA AND DIGITAL WORKSTATION

Applicant Maxxvision, LLC

K number K031372

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LLZ 2003-06-30

SONOVIEW PRO BY MEDISON CO., LTD.

Applicant Medison Co., Ltd.

K number K031886

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LLZ 2003-06-20

INTEGRADWEB BY DYNAMIC IMAGING, INC.

Applicant Dynamic Imaging, Inc.

K number K031311

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LLZ 2003-06-20

CONSULTIVA REPORT STATION, MODEL RS-1

Applicant Miramedica, Inc.

K number K031248

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LLZ 2003-05-29

KODAK DIRECTVIEW PACS/IMAGE MANAGEMENT SYSTEM, KODAK DIRECTVIEW WORKFLOW MANAGER,KODAK DIRECTVIEW CX/DX, KODAK DIRECTVIB

Applicant Eastman Kodak Company

K number K030781

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LLZ 2003-05-29

IPACS PRISM

Applicant Realtimeimage, Inc.

K number K030751

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LLZ 2003-05-23

FYRELINK VL

Applicant Mpacs, LLC

K number K030728

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LLZ 2003-05-02

20.1 MONOCHROME LCD MONITOR, RADIFORCE G20

Applicant Eizo Nanao Corporation

K number K030347

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LLZ 2003-04-25

FLAT PANEL DISPLAYS, CDL SERIES

Applicant Totoku Electric Co., Ltd.

K number K030276

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LLZ 2003-04-25

MEDICAL FLAT PANEL DISPLAY, ME315L

Applicant Totoku Electric Co., Ltd.

K number K030274

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LLZ 2003-04-25

FLAT PANEL DISPLAY, ME183L

Applicant Totoku Electric Co., Ltd.

K number K030272

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LLZ 2003-04-17

INFINTT CO., LTD. STARPACS SYSTEM

Applicant Infinitt Company

K number K031013

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LLZ 2003-04-08

SYNGO COLONOGRAPHY SOFTWARE PACKAGE

Applicant Siemens Medical Solutions USA, Inc.

K number K030982

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LLZ 2003-04-08

REX, VERSION 3.0

Applicant Pointdx, Inc.

K number K030457

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LLZ 2003-03-28

THE OBSIDIAN PACS SYSTEM

Applicant Obsidian Medical Technology, Inc.

K number K030635

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LLZ 2003-03-27

ORG@NIZER, MODEL VERSION 3.0

Applicant Ebit Sanita, S.P.A.

K number K030363

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LLZ 2003-03-25

20.1 MONOCHROME LCD MONITOR, RADIFORCE G21

Applicant Eizo Nanao Corporation

K number K024358

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LLZ 2003-03-10

FYRELINK

Applicant Mpacs, LLC

K number K030242

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LLZ 2003-03-10

STRYKERWARE SYSTEM

Applicant Stryker Endoscopy

K number K024159

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LLZ 2003-02-06

SONOCALC

Applicant Sonometric Health, LLC

K number K030223

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LLZ 2003-02-05

OBSERVER ULTRASOUND REPORTING AND IMAGING SYSTEM

Applicant Vision Chips, Inc.

K number K022877

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LLZ 2003-01-24

IVUS PLUS

Applicant Indec Systems, Inc.

K number K024103

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LLZ 2003-01-24

SHARP VIEW IMAGE ENHANCEMENT SYSTEM

Applicant Context Vision AB

K number K024028

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LLZ 2003-01-17

BARCO MEDIS 5MP2 AURA

Applicant Barco N.V.

K number K023533

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LLZ 2003-01-15

JUPITER PROCESSING AND REVIEW WORKSTATION

Applicant Ge Medical Systems, Inc.

K number K024137

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LLZ 2003-01-09

PACSPLUS

Applicant Medical Standard Co., Ltd.

K number K023460

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LLZ 2003-01-07

UNIPACS WORKSTATION

Applicant Universal Pacs, Inc.

K number K023476

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LLZ 2003-01-07

HCP DICOM NET

Applicant Softlink International, Inc.

K number K023467

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LLZ 2003-01-07

UNISIGHT SYSTEM WITH UNIGATE

Applicant Electronic Business Machine Co., Ltd. (Ebm)

K number K023394

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LLZ 2002-12-23

Q LAB QUANTIFICATION SOFTWARE WITH STRAIN RATE QUANTIFICATION PLUG-IN

Applicant Philips Ultrasound, Inc.

K number K023877

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LLZ 2002-12-23

CORNIS 5MP MEDICAL FLAT PANEL DISPLAY SYSTEM

Applicant Barco N.V.

K number K023341

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LLZ 2002-12-23

CORONIS 1MP MEDICAL FLAT PANEL DISPLAY SYSTEM

Applicant Barco N.V.

K number K023340

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LLZ 2002-12-23

IMAGETILE

Applicant Barco N.V.

K number K023339

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LLZ 2002-12-23

CORONIS 2MP MEDICAL FLAT PANEL DISPLAY SYSTEM

Applicant Barco N.V.

K number K023322

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LLZ 2002-12-23

AMALGA PACS

Applicant Global Care Solutions, S.A.

K number K023246

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LLZ 2002-12-20

MODIFICATION TO MEDIPRIME

Applicant Algotec Systems, Ltd.

K number K023936

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LLZ 2002-12-19

PHILIPS EASYVISION WORKSTATION RELEASE 6

Applicant Philips Medical Systems North America Co.

K number K023137

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LLZ 2002-12-13

BARCO MEDIS 2MP1NT MEDICAL DIAGNOSTIC DISPLAY SYSTEM

Applicant Barco N.V.

K number K022773

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LLZ 2002-11-22

KINETDX PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM

Applicant Acuson Corp.

K number K023772

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LLZ 2002-11-22

AMICAS LIGHT BEAM WORKSTATION, MODEL 1.0

Applicant Amicas, Inc.

K number K022970

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LLZ 2002-11-20

IMAGECHECKER-CT WORKSTATION

Applicant R2 Technology, Inc.

K number K023003

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LLZ 2002-11-07

CENTRICITY PACS PLUS

Applicant GE Medical Systems

K number K023557

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LLZ 2002-10-30

PHILIPS DIGITAL IMAGING OPTION RELEASE 1

Applicant Philips Medical Systems

K number K023440

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LLZ 2002-10-25

VIZDEXTER VERSION 2.0; DEXTROSCOPE MK8; DEXTROBEAM MK3

Applicant Volume Interactions Pte, Ltd.

K number K022938

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LLZ 2002-10-25

PHILIPS HARMONY RELEASE 1

Applicant Philips Medical Systems North America Co.

K number K022788

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LLZ 2002-10-24

E.CAM COMPUTER / E.SOFT WORKSTATION

Applicant Siemens Medical Solutions USA, Inc.

K number K023190

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LLZ 2002-10-22

CEDARA I-SOFTVIEW

Applicant Cedara Software Corp.

K number K022881

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LLZ 2002-10-17

ECHO-VIEW 5.X, EASY-VIEW 2.X, OMNI VIEW 2.X, CARDIO-VIEW 1.X, LV ANALYSIS 1.X & SURGICAL VIEW 1.X

Applicant Tomtec Imaging Systems GmbH

K number K022824

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LLZ 2002-10-11

ACCUSKETCH CARDIAC QUANTITATIVE SYSTEM W/ ADVANCED ANALYSIS COMPONENTS

Applicant General Electric Medical Systems Information Techn

K number K023100

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LLZ 2002-10-11

IN-VISION VIEW WITH MEASUREMENTS MODULE, MODEL 1.0

Applicant Intelligent Images Srl

K number K022940

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LLZ 2002-10-11

SMARTPACS

Applicant Taiwan Electronic Data Processing Corporation

K number K022710

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LLZ 2002-10-11

VOXELPLUS PACS

Applicant Mevisys Co., Ltd.

K number K022692

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LLZ 2002-10-11

KIMAX QMA

Applicant Medical Metrics, Inc.

K number K022585

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LLZ 2002-10-03

CSV12 SOFTWARE VIEWER

Applicant Acuson Corp.

K number K022896

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LLZ 2002-09-12

IMPAX DIAGNOSTIC DISPLAY STATION,IMPAX CLINICAL REVIEW STATION,IMPAX FOR CARDIOLOGY CLINICAL REVIEW SATATION,IMPAX ORTHO

Applicant Agfa Corp.

K number K022292

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LLZ 2002-09-06

VIATRONIX V3D EXPLORER

Applicant Viatronix, Inc.

K number K022789

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LLZ 2002-09-06

CALSCOR SOFTWARE

Applicant 3D Med Co., Ltd.

K number K021913

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LLZ 2002-08-19

FLAT PANEL DISPLAYS, ME SERIES & CCL SERIES

Applicant Totoku Electric Co., Ltd.

K number K021738

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LLZ 2002-08-12

MODIFICATION TO MEDSTATION

Applicant Aisoftw@Re Medical, S.P.A.

K number K021934

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LLZ 2002-08-12

PATXFER

Applicant Brainlab AG

K number K021583

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LLZ 2002-08-06

QUANTITATIVE BLOOD POOL SPECT (QBS)

Applicant Adac Laboratories

K number K022428

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LLZ 2002-08-01

ADVANTAGE WINDOWS X-RAY/MR FUSION

Applicant Ge Medical Systems, Inc.

K number K022310

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LLZ 2002-07-17

SURGERY AND ACCESSORIES

Applicant Camtronics, Ltd.

K number K021236

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LLZ 2002-07-12

EIZO, MODEL FC-2091

Applicant Eizo Nanao Corporation

K number K022109

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LLZ 2002-07-12

AUTOALIGN

Applicant Cortechs Labs, Inc.

K number K021191

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LLZ 2002-07-12

MEDICAL ADMINISTRATOR

Applicant Barco N.V.

K number K020073

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LLZ 2002-07-02

Q LAB SOFTWARE

Applicant Advanced Technology Laboratories, Inc.

K number K021966

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LLZ 2002-07-02

SCEPTRE-VS

Applicant Hitachi Medical Systems America, Inc.

K number K021314

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LLZ 2002-06-27

REX, VERSION 1.0

Applicant Pointdx, Inc.

K number K021099

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LLZ 2002-06-06

FILMSAVER, NT VERSION 5.03

Applicant American Medical Resources, Ltd. (Amr)

K number K021072

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LLZ 2002-06-05

PHYSICIAN'S DESKTOP REVIEW

Applicant Adac Laboratories

K number K021669

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LLZ 2002-05-10

CARDIONOW CARDIOLOGY WIDE AREA ARCHIVE AND RETRIEVAL SYSTEM

Applicant Cardionow, Inc.

K number K020449

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LLZ 2002-04-26

FUSION 7D

Applicant Mirada Solutions , Ltd.

K number K020546

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LLZ 2002-04-12

EFILM WORKSTATION WITH MODULES

Applicant Efilm Medical, Inc.

K number K020995

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LLZ 2002-04-04

MEDICAL LE

Applicant Barco N.V.

K number K020058

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LLZ 2002-04-03

IMAGEDESK

Applicant Barco N.V.

K number K020061

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LLZ 2002-04-03

MFCD 118I

Applicant Barco N.V.

K number K020059

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LLZ 2002-03-07

VIATRONIX V3D COLON

Applicant Viatronix, Inc.

K number K020658

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