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 2002-02-28

ADVANTAGE WORKSTATION 4.1

Applicant GE Medical Systems

K number K020483

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LLZ 2002-02-06

DENTALEYE 2 DENTAL IMAGE MANAGEMENT SYSTEM

Applicant Radco Data AB

K number K012439

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LLZ 2002-02-01

MODIFICATION TO VIEWSEND MEDICAL

Applicant Klt Telecom, Inc.

K number K013994

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LLZ 2002-01-28

VOXAR'S CALCIUM SCORING PRODUCT

Applicant Voxar Limited

K number K020140

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LLZ 2002-01-28

CORONIS 3MP MEDICL FLAT PANEL DISPLAY SYSTEM

Applicant Barco N.V.

K number K013922

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LLZ 2002-01-17

3DFIS, MODEL IES-FL-101

Applicant 3Dsharp, Inc.

K number K013841

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LLZ 2002-01-15

ACCENT

Applicant Confirma, Inc.

K number K013574

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LLZ 2001-12-21

ENTEGRA PE PERSONAL DIGITAL ASSISTANT

Applicant General Electric Medical Systems

K number K014058

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LLZ 2001-12-20

NICOLET ELECTROMAGNETIC NAVIGATION SYSTEM

Applicant Nicolet Biomedical

K number K013419

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LLZ 2001-12-20

CSIST DICOM GATEWAY/IMAGE MANAGER

Applicant Csist

K number K012327

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LLZ 2001-12-07

CYBERMED, INC., V-WORKS

Applicant Cybermed, Inc.

K number K013878

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LLZ 2001-12-07

KIMAX REMOTE VIEWING STATION

Applicant Medical Metrics, Inc.

K number K013098

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LLZ 2001-12-05

ISITE RADIOLOGY

Applicant Stentor, Inc.

K number K013630

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LLZ 2001-11-08

MAROSIS PACS

Applicant Marotech, Inc.

K number K012844

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LLZ 2001-11-08

IQUANTIFY, VERSION 1.0

Applicant Insightful Corporation

K number K011196

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LLZ 2001-11-02

ICONNECTION 3D

Applicant Hinnovation, Inc.

K number K012779

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LLZ 2001-11-02

DEEP GRAY

Applicant Cortechs Labs, Inc.

K number K012563

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LLZ 2001-10-24

CAAS II QVA

Applicant Pie Medical Imaging BV

K number K012475

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LLZ 2001-09-28

RAPIDIA

Applicant 3D Med Co., Ltd.

K number K012290

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LLZ 2001-09-21

AETMED IMAGE PROCESSING SOFTWARE

Applicant Aetmed, S.P.A.

K number K012093

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LLZ 2001-09-13

AQUARIUSNET SERVER

Applicant Terarecon,Inc.

K number K012086

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LLZ 2001-08-29

VIEWSTATION

Applicant Impac Medical Systems, Inc.

K number K011694

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LLZ 2001-08-10

KODAK RADIATION ONCOLOGY SOFTWARE/ FOR ACR SYSTEMS

Applicant Eastman Kodak Company

K number K012155

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LLZ 2001-07-31

EFILM WORKSTATION

Applicant Efilm Medical, Inc.

K number K012211

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LLZ 2001-07-31

MONOCHROME PERFECTLY FLAT PANEL DISPLAYS, ME SERIES

Applicant Totoku Electric Co., Ltd.

K number K012099

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LLZ 2001-07-31

QCU ANALYTICAL SOFTWARE PACKAGE

Applicant Medis Medical Imaging Systems BV

K number K011582

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LLZ 2001-07-12

VORTEX

Applicant Ultravisual Medical Systems

K number K012097

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LLZ 2001-07-12

VOXAR VC, MODEL 1.0

Applicant Voxar Limited

K number K012072

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LLZ 2001-07-11

TELEPAX

Applicant Imed Systems & Consulting, LLC

K number K011173

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LLZ 2001-06-26

SYNGO MULTIMODALITY WORKSTATION

Applicant Siemens Medical Solutions USA, Inc.

K number K010938

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LLZ 2001-06-07

XSCAN32 TELERADIOLOGY SOFTWARE

Applicant Radiographic Digital Imaging, Inc.

K number K002911

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LLZ 2001-05-25

GOODNET

Applicant Goodman Co., Ltd.

K number K010763

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LLZ 2001-05-08

AQUARIUS WORKSTATION

Applicant Terarecon,Inc.

K number K011142

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LLZ 2001-04-26

MODIFICATION TO MIRAGE

Applicant Segami Corp., Inc.

K number K010726

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LLZ 2001-04-26

MEDIFACE PACS

Applicant Mediface Co., Ltd.

K number K010259

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LLZ 2001-04-03

THINKINGNET

Applicant Thinking Systems Corp.

K number K010271

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LLZ 2001-03-28

ADC QS/IPD WORKSTATION

Applicant Agfa Corp.

K number K010571

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LLZ 2001-03-21

IMAGE IV DICOM IMAGE ARCHIVAL PACS NETWORK

Applicant Witt Biomedical Corporation

K number K010058

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LLZ 2001-03-21

MEDEVIEW SYSTEM

Applicant Medeview.Com

K number K002789

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LLZ 2001-03-13

3D-DOCTOR

Applicant Able Software Corp.

K number K003746

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LLZ 2001-02-28

ALI 3D TOOL MODULE FOR MEDICAL IMAGES

Applicant A.L.I. Technologies, Inc.

K number K003762

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LLZ 2001-02-16

ADVANTAGE WINDOWS CT/PET FUSION

Applicant Ge Medical Systems, Inc.

K number K010336

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LLZ 2001-02-15

ONYX-RAD TELEMEDICINE PACS

Applicant Viztek, Inc.

K number K003607

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LLZ 2001-02-12

INSTATRAK SYSTEM WITH FLUOROCAT, MODEL IT3500

Applicant Visualization Technology, Inc.

K number K003510

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LLZ 2001-02-02

ODYSSEY LX, MODEL 211320

Applicant Philips Medical Systems (Cleveland), Inc.

K number K003437

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LLZ 2001-01-22

VIEW READING STATION

Applicant Electromed Intl., Ltd.

K number K003688

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LLZ 2001-01-22

PHILIPS EASY VISION FAMILY WORKSTATION OPTION MR QUANTITATIVE FLOW

Applicant Philips Medical Systems North America, Inc.

K number K003459

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LLZ 2001-01-19

NETRA WORKSTATION AND NETRAMD SOFTWARE

Applicant Scimage, Inc.

K number K003484

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LLZ 2000-12-19

PHILIPS EASY VISION FAMILY WORKSTATION OPTION CARDIRAC SCORING

Applicant Philips Medical Systems North America, Inc.

K number K002942

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LLZ 2000-12-11

EBT ULTRAFAST CT SCANNER SYSTEM; C-100, C-150, C-150LXP OR C-150XP SCANNER SYSTEMS; ELECTRON BEAM SCANNER SYSTEM; ELECTR

Applicant Imatron, Inc.

K number K001550

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LLZ 2000-12-05

MEDIPRIME

Applicant Algotec Systems, Ltd.

K number K002894

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LLZ 2000-12-05

HERMES HD AQ ACQUISITION STATION AND HERMES WORKSTATION

Applicant Nuclear Diagnostics AB

K number K002782

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LLZ 2000-11-22

T.I.M.S., VERSION 2.00

Applicant Total Medical Information Management Systems, Inc.

K number K001947

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LLZ 2000-11-17

VIATRONIX VISUALIZATION SYSTEM (VVS)

Applicant Viatronix, Inc.

K number K002780

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LLZ 2000-11-17

NUMALINK

Applicant Numa, Inc.

K number K002724

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LLZ 2000-11-17

CN ACQUISITION STATION

Applicant Cardionow, Inc.

K number K002597

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LLZ 2000-10-31

CEDARA CARDIOLOGY VIEWER, CARDIOLOGY ARCHIVE VIEWER, CARDIOLOGY CD VIEWER

Applicant Cedara Software Corp.

K number K002590

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LLZ 2000-10-27

3D ANGIOGRAPHIC IMAGING SYSTEM, MODEL XIDF-100A

Applicant Toshiba America Medical Systems, In.C

K number K002424

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LLZ 2000-10-19

VITREA 2, VERSION 2.1

Applicant Vital Images, Inc.

K number K002519

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LLZ 2000-10-17

MODIFICATION TO IDS5 IMAGE DISPLAY SYSTEM

Applicant Sectra-Imtec AB

K number K002936

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LLZ 2000-09-28

MEDLINK DIAGNOSTIC OFFLINE WORKSTATION

Applicant Advanced Technology Laboratories, Inc.

K number K002144

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LLZ 2000-09-27

ECAT PET SCANNER, MODELS ECAT EXACT AND ECAT EXACT HR+ AND ECAT ART

Applicant Cti Pet Systems, Inc.

K number K002039

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LLZ 2000-08-25

XIMX SYSTEM

Applicant Medical Manager Research Development

K number K002100

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LLZ 2000-07-27

MEDIS 5MP2 DUAL-HEAD MEDICAL DIAGNOSTIC DISPLAY SYSTEM

Applicant Barco NV Display Systems

K number K001753

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LLZ 2000-07-27

MEDIS 5MP2 QUAD-HEAD MEDICAL DIAGNOSTIC DISPLAY SYSTEM

Applicant Barco NV Display Systems

K number K001748

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LLZ 2000-07-21

MEDIS 5MP1H QUAD-HEAD MEDICIAL DIAGNOSTIC DISPLAY SYSTEM

Applicant Barco NV Display Systems

K number K001750

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LLZ 2000-07-19

MEDIS 5MP1H DUAL-HEAD MEDICAL DIAGNOSTIC DISPLAY SYSTEM

Applicant Barco NV Display Systems

K number K001754

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LLZ 2000-07-19

MEDIS 55MP1H SINGLE-HEAD MEDICAL DIAGNOSTIC DISPLAY SYSTEM

Applicant Barco NV Display Systems

K number K001752

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LLZ 2000-07-19

MEDIS 2MP2 QUAD-HEAD MEDICAL DIAGNOSTIC DISPLAY SYSTEM

Applicant Barco NV Display Systems

K number K001751

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LLZ 2000-07-13

MEDIS 2MP2 DUAL-HEAD MEDICAL DIAGNOSTIC DISPLAY SYSTEM

Applicant Barco NV Display Systems

K number K001747

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LLZ 2000-07-06

LIFERX

Applicant Bowdengs Technologies, LLC

K number K001596

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LLZ 2000-06-13

DIGITAL INTEGRATION SYSTEM, DIS2000

Applicant Wellington Medical Systems, Inc.

K number K001012

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LLZ 2000-05-16

PROVIEW MEDICAL IMAGE DISPLAY MODULE

Applicant Cerner Corp.

K number K000770

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LLZ 2000-05-12

MODELS PRIAM (FAMILY OF DEVICES) DIGITAL IMAGING SYSTEM

Applicant Hopkins Imaging Systems, Inc.

K number K000630

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LLZ 2000-05-03

IDS5 IMAGE DISPLAY SYSTEM

Applicant Sectra AB

K number K001140

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LLZ 2000-05-03

EINSTEIN PROCESSING AND REVIEW WORKSTATION

Applicant Ge Medical Systems F.I. Haifa

K number K000395

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LLZ 2000-05-03

FOTOMASTER

Applicant Hamilton Thorne Research

K number K000380

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LLZ 2000-04-24

MEDVIZER PACS, MODEL RELEASE 2000

Applicant Vitel Net

K number K000557

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LLZ 2000-04-24

REMOTE FETAL MEDICINE ULTRASOUND SYSTEM

Applicant R4 Telemedicine, Inc.

K number K000443

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LLZ 2000-04-20

PACSSTATION

Applicant Fernandez Industries, Inc.

K number K000448

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LLZ 2000-04-19

VIEW NT

Applicant Electromed Intl., Ltd.

K number K000474

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LLZ 2000-03-29

BARCO MGD 221 2 MEGAPIXEL DIAGNOSTIC DISPLAY

Applicant Barco N.V.

K number K000293

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LLZ 2000-03-29

BARCO MWD 321 PLUS MEDICAL WORKSTATION DISPLAY

Applicant Barco N.V.

K number K000292

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LLZ 2000-03-27

MFCD 120

Applicant Barco N.V.

K number K000294

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LLZ 2000-03-27

MFCD 118

Applicant Barco N.V.

K number K000291

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LLZ 2000-03-14

BARCOMED 5MP2

Applicant Barco N.V.

K number K000016

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LLZ 2000-03-14

BARCOMED 5MP1H

Applicant Barco N.V.

K number K000014

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LLZ 2000-03-09

INSTATRAK 3000 SYSTEM WITH FLUOROTRAK MODULE, MODEL IT3000

Applicant Visualization Technology, Inc.

K number K994270

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LLZ 2000-03-09

PEGASYS ULTRA

Applicant Adac Laboratories

K number K993946

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LLZ 2000-02-22

REMOTEIMAGE SYSTEM

Applicant Etrauma.Com Corp.

K number K994228

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LLZ 2000-02-14

ISSA PHAROS

Applicant Vams Tec, D.O.O.

K number K994054

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LLZ 2000-02-04

INTURIS SUITE

Applicant Philips Medical Systems, Inc.

K number K994210

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LLZ 2000-02-04

BARCOMED 2MP2

Applicant Barco N.V.

K number K000015

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LLZ 2000-02-02

PROSOLV ECHOVIEWER, PROSOLV ECHOVIEWER SE, PROSOLV ECHOANALYZER, PROSOLV ECHOSERV, PROSOLV ECHO

Applicant Problem Solving Concepts, Inc.

K number K993750

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LLZ 2000-01-18

SHARPVIEW IMAGE ENHANCEMENT SYSTEM

Applicant Context Vision AB

K number K993802

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LLZ 1999-12-29

INTEGRATED DIGITAL MEDICAL RECORD (IDMR)

Applicant Ibm Israel , Ltd.

K number K993338

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LLZ 1999-12-29

OSCAR NET/CD, MODEL M1.82 600 . O/A/B/C

Applicant Arnold & Richter Cine Technik

K number K993283

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LLZ 1999-12-28

CARDIOVASCULAR MEASUREMENT SYSTEM - VIEW

Applicant Medis Medical Imaging Systems BV

K number K993761

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LLZ 1999-12-21

PHILIPS INTURIS DICOM RECORDER

Applicant Philips Medical Systems North America, Inc.

K number K993227

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LLZ 1999-12-15

DDS, DS3000, RS3000, CS5000, OT3000, IS3000, RS5000, CD3000, US3000, (AMONGST OTHER NAMES)

Applicant Impax Technology, Inc.

K number K993532

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