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 2004-11-08

IMAGE MEDICAL ACQUISITION STATION (IMAS)

Applicant Erad Imagemedical Corp.

K number K042700

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LLZ 2004-11-02

PHILIPS ORTHOPAEDIC APPLICATIONS

Applicant Philips Medical Systems North America, Inc.

K number K042867

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LLZ 2004-10-28

SIENET COSMOS (VERSION V15A)

Applicant Siemens AG Medical Solutions

K number K042832

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LLZ 2004-10-21

IMPLANTMASTER

Applicant I-Dent

K number K042212

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LLZ 2004-10-20

RSA-CMS

Applicant Medis Medical Imaging Systems BV

K number K042383

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LLZ 2004-10-19

IPACS CARDIO

Applicant Realtimeimage, Inc.

K number K042781

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LLZ 2004-10-08

WIDE 1MP LCD MONITOR SYSTEM

Applicant Wide Corporation

K number K042634

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LLZ 2004-10-07

CLARITY FUSION

Applicant Shared P.E.T. Imaging, LLC

K number K042692

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LLZ 2004-10-07

EXAM-PACS

Applicant Coactiv, LLC

K number K042647

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LLZ 2004-10-01

CENTRICITY RADIOLOGY RA600/CENTRICITY CARDIOLOGY CA1000/CENTRICITY DIGITAL HARDCOPY WORKSTATION

Applicant Ge Medical Systems Information Technologies

K number K042525

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LLZ 2004-09-27

UBIPACS

Applicant Icm Co., Ltd.

K number K042507

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LLZ 2004-09-27

ALLURA 3D-CA, RELEASE 1

Applicant Philips Medical Systems North America Co.

K number K042334

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LLZ 2004-09-24

LEONARDO SYNGO CARDIOLOGY WORKSTATION

Applicant Siemens Medical Solutions USA, Inc.

K number K042203

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LLZ 2004-09-21

ULTRASOUND CAPTURE SYSTEM

Applicant Heartlab, Inc.

K number K042042

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LLZ 2004-09-09

INTEGRADWEB MPR/MIP

Applicant Dynamic Imaging, Inc.

K number K042313

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LLZ 2004-09-09

PACSPARTNER

Applicant Medical Standard Co., Ltd.

K number K042311

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LLZ 2004-09-08

ISITE PACS

Applicant Stentor, Inc.

K number K042292

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LLZ 2004-09-03

ULTRAVISUAL

Applicant Emageon Uv, Inc.

K number K042008

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LLZ 2004-08-27

BARCOVIEW CORONIS 5MP HD MEDICAL FLAT PANEL DISPLAY SYSTEM

Applicant Barco NV Barcoview

K number K041508

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LLZ 2004-08-16

DR SYSTEMS PACS, RELEASE 6.1

Applicant Dr Systems, Inc.

K number K041935

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LLZ 2004-08-16

SEEMOR 5.0 IMAGE DISPLAY PROGRAM

Applicant Areeda Assoc., Ltd.

K number K041782

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LLZ 2004-08-09

SECURVIEW DX SOFTCOPY WORKSTATION

Applicant Hologic, Inc.

K number K041555

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LLZ 2004-08-06

FUJI MEDICAL CR CONSOLE, MODEL FLASH IIP

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

K number K041990

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LLZ 2004-07-30

UNDECIDED

Applicant Siemens Medical Solutions USA, Inc.

K number K041484

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LLZ 2004-07-30

M'ATH STD

Applicant Intelligence IN Medical Technologies

K number K040686

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LLZ 2004-07-27

CAAS MRV

Applicant Pie Medical Imaging BV

K number K041682

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LLZ 2004-07-27

MEDCOMMONS OPEN RADIOLOGY GATEWAY

Applicant Medcommons, Inc.

K number K041326

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LLZ 2004-07-27

ORTHO-CMS

Applicant Medis Medical Imaging Systems BV

K number K041162

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LLZ 2004-07-22

PATXFER RT

Applicant Brainlab AG

K number K040931

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LLZ 2004-07-16

MODIFICATION TO ENCOMPASS

Applicant Heartlab, Inc.

K number K040896

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LLZ 2004-07-13

RAPIDIACOLON

Applicant Infinitt Co., Ltd.

K number K041761

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LLZ 2004-07-13

5M MONOCHROME DIGITAL MAMMOGRAPHY LCD MONITOR ME511L (MDL2105A)

Applicant Totoku Electric Co., Ltd.

K number K041737

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LLZ 2004-07-08

KINETDX

Applicant Siemens Medi Cal Solutions, Inc.

K number K041029

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LLZ 2004-07-08

LEONARDO

Applicant Siemens Medical Systems, Inc.

K number K040970

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LLZ 2004-06-24

MONOCHROME LCD MONITOR, MODEL RADIFORCE G22

Applicant Eizo Nanao Corporation

K number K041597

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LLZ 2004-06-22

COMPACS, VERSION 1.0

Applicant Intelligent Images Srl

K number K041581

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LLZ 2004-06-21

STARPACS ORTHOPEDICS SYSTEM

Applicant Infinitt Co., Ltd.

K number K041500

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LLZ 2004-06-17

NOVA FAMILY OF MEDICAL RADIOLOGY DISPLAYS

Applicant National Display Systems

K number K040310

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LLZ 2004-06-16

DOME CX DIGITAL FLAT-PANEL DISPLAY SYSTEM, MODEL C5I

Applicant Dome Imaging Systems, Inc.

K number K040443

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LLZ 2004-06-10

21.3-INCH (54CM) COLOR LCD MONITOR CCL212 (CDL2107A)

Applicant Totoku Electric Co., Ltd.

K number K040697

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LLZ 2004-06-08

IPACS ORTHO

Applicant Realtimeimage, Inc.

K number K041366

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LLZ 2004-06-08

MRA-CMS

Applicant Medis Medical Imaging Systems BV

K number K040746

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LLZ 2004-06-07

21,3-INCH (54CM) MONOCHROME LCD MONITOR ME213L (MDL2108A)

Applicant Totoku Electric Co., Ltd.

K number K040695

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LLZ 2004-06-02

BARCOVIEW MGD 521M DIGITAL MAMMOGRAPHY DISPLAY

Applicant Barco NV Barcoview

K number K033859

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LLZ 2004-05-27

CT COLONOGRAPHY II

Applicant General Electric Medical Systems

K number K041270

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LLZ 2004-05-26

IMPAX CLIENT EMBRACE

Applicant Agfa Corp.

K number K040555

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LLZ 2004-05-25

SIMPLANT SYSTEM

Applicant Materialise NV

K number K033849

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LLZ 2004-05-13

COLOR LCD MONITOR, MODEL RADIFORCE R12

Applicant Eizo Nanao Corporation

K number K040982

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LLZ 2004-05-12

IMPAX OT3000 ORTHOPEDIC WORKSTATION

Applicant Agfa Corp.

K number K040344

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LLZ 2004-05-11

CRADLE PACS

Applicant Cradle Technology Corp.

K number K033912

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LLZ 2004-05-04

SECTRA IDS5 RADIOLOGY WORKSTATION; SECTRA MPR PACKAGE; SECTRA 3D PACKAGE

Applicant Sectra-Imtec AB

K number K040376

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LLZ 2004-04-28

COLOR CORONIS 2MP MEDICAL FLAT PANEL DISPLAY SYSTEM

Applicant Barco N.V.

K number K040365

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LLZ 2004-04-27

IMAGE-ARENA AND RESEARCH-ARENA APPLICATIONS

Applicant Tomtec Imaging Systems GmbH

K number K040546

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LLZ 2004-04-23

PREVIEW TREATMENT PLANNING SOFTWARE

Applicant Medical Media Systems, Inc.

K number K040852

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LLZ 2004-04-23

CEDARA I-SOFTVIEW AND CEDARA I-READMAMMO

Applicant Cedara Software Corp.

K number K040468

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LLZ 2004-04-23

DICOM THEATER

Applicant Ferguson Medical

K number K033153

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LLZ 2004-04-23

5M MEDICAL FLAT PANEL DISPLAY, ME511L

Applicant Totoku Electric Co., Ltd.

K number K031661

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LLZ 2004-04-20

MIVD 1218 18 INCH GREYSCALE LCD DISPLAY MODULE

Applicant Barco NV Barcoview

K number K033006

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LLZ 2004-04-19

ICONNECTION, VERSION 3.2.0.0 MEDICAL IMAGE PROCESSING SOFTWARE

Applicant Vital Images, Inc.

K number K040876

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LLZ 2004-04-19

VIATRONIX V3D COLON, REVISION 1.3

Applicant Viatronix, Inc.

K number K040126

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LLZ 2004-04-19

MGD 2621P MEDICAL GREYSCALE DISPLAY

Applicant Barco NV Barcoview

K number K033104

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LLZ 2004-04-19

MFGD 1318 18 INCH 1 MEGAPIXEL GREYSCALE LCD DISPLAY

Applicant Barco NV Barcoview

K number K033005

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LLZ 2004-04-16

MGD 2621L MEDICAL GREYSCALE DISPLAY

Applicant Barco NV Barcoview

K number K033103

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LLZ 2004-04-16

MFGD 2320 20 INCH 2 MEGAPIXEL GREYSCALE LCD DISPLAY

Applicant Barco NV Barcoview

K number K033004

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LLZ 2004-04-12

MFCD 2320

Applicant Barco N.V.

K number K040158

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LLZ 2004-04-07

CALYSTO IMAGE IV-IMAGE AND INFORMATION MANAGEMENT SYSTEM

Applicant Witt Biomedical Corp

K number K040195

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LLZ 2004-03-29

QONTRAST

Applicant Amid

K number K040399

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LLZ 2004-03-29

NIO 3MP MEDICAL GRAYSCALE DISPLAY SYSTEM

Applicant Barco NV Barcoview

K number K040041

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LLZ 2004-03-29

NIO 5MP MEDICAL GRAYSCALE DISPLAY SYSTEM

Applicant Barco NV Barcoview

K number K040040

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LLZ 2004-03-24

INSTATRAK SYSTEM WITH MULTIPLE DATASET NAVIGATION, MODEL IT3500

Applicant Ge Medical Systems Navigation and Visualization IN

K number K040050

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LLZ 2004-03-17

NIO 2MP MEDICAL GRAYSCALE DISPLAY SYSTEM

Applicant Barco N.V.

K number K040039

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LLZ 2004-03-17

RTIST

Applicant Mirada Solutions , Ltd.

K number K033955

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LLZ 2004-03-17

CAAS II RVA

Applicant Pie Medical Imaging BV

K number K033920

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LLZ 2004-03-11

MEDIPACS

Applicant Neobit Co., Ltd.

K number K040486

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LLZ 2004-03-09

SECTRA ANGIOGRAPHY PACKAGE AND SECTRA CARDIOLOGY PACKAGE

Applicant Sectra AB

K number K034059

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LLZ 2004-02-26

3M COLOR MEDICAL FLAT PANEL DISPLAY, CCL316

Applicant Totoku Electric Co., Ltd.

K number K032555

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LLZ 2004-02-24

VITREA2 VERSION 3.5

Applicant Vital Images, Inc.

K number K040305

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LLZ 2004-02-20

COLOR LCD DISPLAY, MODEL RADIFORCE R22

Applicant Eizo Nanao Corporation

K number K033466

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LLZ 2004-02-19

INTEGRIS 3D-RA, RELEASE 4.2

Applicant Philips Medical Systems North America Co.

K number K040254

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LLZ 2004-02-17

QLAB QUANTIFICATION SOFTWARE

Applicant Philips Ultrasound

K number K040227

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LLZ 2004-02-06

ENSPHERE TEMPO JETSTREAM WORKSPACE CARDIOLOGY MODULE

Applicant Adac Laboratories

K number K040142

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LLZ 2004-02-02

ORTHOPACS

Applicant Etrauma.Com Corp.

K number K033825

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LLZ 2004-02-02

CHASE CARDIAC ANALYSIS SYSTEM

Applicant Chase Medical, Inc.

K number K032531

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LLZ 2004-01-22

CA-1500

Applicant R2 Technology, Inc.

K number K040028

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LLZ 2003-12-23

MODIFICATION TO SECTRA IDS5 RADIOLOGY WORKSTATION - VERSION 10.1

Applicant Sectra-Imtec AB

K number K033712

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LLZ 2003-12-19

SIENET COSMOS

Applicant Siemens AG Medical Solutions

K number K033831

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LLZ 2003-12-15

PACS SOFTWARE SOLUTION 2003

Applicant Canon USA, Inc.

K number K033624

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LLZ 2003-12-04

SENO ADVANTAGE

Applicant Ge Medical Systems W-400

K number K033400

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LLZ 2003-11-26

CONSULTIVA CASE INPUT STATION, MODEL CIS-1

Applicant Eastman Kodak Company

K number K031132

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LLZ 2003-11-25

MDIFICATION TO MEDIPRIME

Applicant Algotec Systems, Ltd.

K number K033013

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LLZ 2003-11-05

VIATRONIX V3D VASCULAR, REVISION 1.0

Applicant Viatronix, Inc.

K number K033361

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LLZ 2003-11-05

ECHOCONNEX COMMUNICATOR

Applicant Connexmd

K number K033093

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LLZ 2003-10-30

RATIONAL IMAGING PACS

Applicant Intuitive Imaging Informatics, LLC

K number K031473

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LLZ 2003-10-29

SECTRA IDS5 RADIOLOGY WORKSTATION VERSION 10.1

Applicant Sectra AB

K number K033088

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LLZ 2003-10-29

VITREA2, VERSION 3.4 MEDICAL IMAGE PROCESSING SOFTWARE

Applicant Vital Images, Inc.

K number K032748

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LLZ 2003-10-16

HOLOGIC DR IMAGEPRO

Applicant Hologic, Inc.

K number K032546

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LLZ 2003-10-16

INTELEPACS

Applicant Intelerad Medical Systems, Inc.

K number K032533

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LLZ 2003-10-14

AUTOALIGN

Applicant Cortechs Labs, Inc.

K number K032186

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LLZ 2003-10-10

RADIODEXTER VERSION 1.0, DEXTROSCOPE, MODEL MK10 AND DEXTROBEAM, MODEL MK3

Applicant Volume Interactions Pte, Ltd.

K number K032924

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LLZ 2003-10-08

WIDE 2MP TFT LCD MONITOR SYSTEM IF 1902A

Applicant Wide Corporation

K number K032960

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