FDA Product Code
FDA Product Code LLZ — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Radiology
- 21 CFR Citation
- 892.2050
510(k) Clearances — 2,293 records · page 20 of 23
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K023936 | MODIFICATION TO MEDIPRIME | Algotec Systems, Ltd. | 2002-12-20 | Special | PDF ↗ |
| K023137 | PHILIPS EASYVISION WORKSTATION RELEASE 6 | Philips Medical Systems North America Co. | 2002-12-19 | Traditional | PDF ↗ |
| K022773 | BARCO MEDIS 2MP1NT MEDICAL DIAGNOSTIC DISPLAY SYSTEM | Barco N.V. | 2002-12-13 | Traditional | PDF ↗ |
| K023772 | KINETDX PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM | Acuson Corp. | 2002-11-22 | Traditional | PDF ↗ |
| K022970 | AMICAS LIGHT BEAM WORKSTATION, MODEL 1.0 | Amicas, Inc. | 2002-11-22 | Traditional | PDF ↗ |
| K023003 | IMAGECHECKER-CT WORKSTATION | R2 Technology, Inc. | 2002-11-20 | Traditional | PDF ↗ |
| K023557 | CENTRICITY PACS PLUS | GE Medical Systems | 2002-11-07 | Traditional | PDF ↗ |
| K023440 | PHILIPS DIGITAL IMAGING OPTION RELEASE 1 | Philips Medical Systems | 2002-10-30 | Traditional | PDF ↗ |
| K022788 | PHILIPS HARMONY RELEASE 1 | Philips Medical Systems North America Co. | 2002-10-25 | Traditional | PDF ↗ |
| K022938 | VIZDEXTER VERSION 2.0; DEXTROSCOPE MK8; DEXTROBEAM MK3 | Volume Interactions Pte, Ltd. | 2002-10-25 | Traditional | PDF ↗ |
| K023190 | E.CAM COMPUTER / E.SOFT WORKSTATION | Siemens Medical Solutions USA, Inc. | 2002-10-24 | Special | PDF ↗ |
| K022881 | CEDARA I-SOFTVIEW | Cedara Software Corp. | 2002-10-22 | Traditional | PDF ↗ |
| K022824 | ECHO-VIEW 5.X, EASY-VIEW 2.X, OMNI VIEW 2.X, CARDIO-VIEW 1.X, LV ANALYSIS 1.X & SURGICAL VIEW 1.X | Tomtec Imaging Systems GmbH | 2002-10-17 | Special | PDF ↗ |
| K022692 | VOXELPLUS PACS | Mevisys Co., Ltd. | 2002-10-11 | Traditional | PDF ↗ |
| K022585 | KIMAX QMA | Medical Metrics, Inc. | 2002-10-11 | Traditional | PDF ↗ |
| K022940 | IN-VISION VIEW WITH MEASUREMENTS MODULE, MODEL 1.0 | Intelligent Images Srl | 2002-10-11 | Traditional | PDF ↗ |
| K023100 | ACCUSKETCH CARDIAC QUANTITATIVE SYSTEM W/ ADVANCED ANALYSIS COMPONENTS | General Electric Medical Systems Information Techn | 2002-10-11 | Special | PDF ↗ |
| K022710 | SMARTPACS | Taiwan Electronic Data Processing Corporation | 2002-10-11 | Traditional | PDF ↗ |
| K022896 | CSV12 SOFTWARE VIEWER | Acuson Corp. | 2002-10-03 | Special | PDF ↗ |
| K022292 | IMPAX DIAGNOSTIC DISPLAY STATION,IMPAX CLINICAL REVIEW STATION,IMPAX FOR CARDIOLOGY CLINICAL REVIEW SATATION,IMPAX ORTHO | Agfa Corp. | 2002-09-12 | Traditional | PDF ↗ |
| K022789 | VIATRONIX V3D EXPLORER | Viatronix, Inc. | 2002-09-06 | Traditional | PDF ↗ |
| K021913 | CALSCOR SOFTWARE | 3D Med Co., Ltd. | 2002-09-06 | Traditional | PDF ↗ |
| K021738 | FLAT PANEL DISPLAYS, ME SERIES & CCL SERIES | Totoku Electric Co., Ltd. | 2002-08-19 | Traditional | PDF ↗ |
| K021583 | PATXFER | Brainlab AG | 2002-08-12 | Traditional | PDF ↗ |
| K021934 | MODIFICATION TO MEDSTATION | Aisoftw@Re Medical, S.P.A. | 2002-08-12 | Traditional | PDF ↗ |
| K022428 | QUANTITATIVE BLOOD POOL SPECT (QBS) | Adac Laboratories | 2002-08-06 | Traditional | PDF ↗ |
| K022310 | ADVANTAGE WINDOWS X-RAY/MR FUSION | Ge Medical Systems, Inc. | 2002-08-01 | Traditional | PDF ↗ |
| K021236 | SURGERY AND ACCESSORIES | Camtronics, Ltd. | 2002-07-17 | Traditional | PDF ↗ |
| K021191 | AUTOALIGN | Cortechs Labs, Inc. | 2002-07-12 | Abbreviated | PDF ↗ |
| K020073 | MEDICAL ADMINISTRATOR | Barco N.V. | 2002-07-12 | Traditional | PDF ↗ |
| K022109 | EIZO, MODEL FC-2091 | Eizo Nanao Corporation | 2002-07-12 | Traditional | PDF ↗ |
| K021966 | Q LAB SOFTWARE | Advanced Technology Laboratories, Inc. | 2002-07-02 | Traditional | PDF ↗ |
| K021314 | SCEPTRE-VS | Hitachi Medical Systems America, Inc. | 2002-07-02 | Traditional | PDF ↗ |
| K021099 | REX, VERSION 1.0 | Pointdx, Inc. | 2002-06-27 | Traditional | PDF ↗ |
| K021072 | FILMSAVER, NT VERSION 5.03 | American Medical Resources, Ltd. (Amr) | 2002-06-06 | Traditional | PDF ↗ |
| K021669 | PHYSICIAN'S DESKTOP REVIEW | Adac Laboratories | 2002-06-05 | Traditional | PDF ↗ |
| K020449 | CARDIONOW CARDIOLOGY WIDE AREA ARCHIVE AND RETRIEVAL SYSTEM | Cardionow, Inc. | 2002-05-10 | Traditional | PDF ↗ |
| K020546 | FUSION 7D | Mirada Solutions , Ltd. | 2002-04-26 | Traditional | PDF ↗ |
| K020995 | EFILM WORKSTATION WITH MODULES | Efilm Medical, Inc. | 2002-04-12 | Traditional | PDF ↗ |
| K020058 | MEDICAL LE | Barco N.V. | 2002-04-04 | Traditional | PDF ↗ |
| K020061 | IMAGEDESK | Barco N.V. | 2002-04-03 | Traditional | PDF ↗ |
| K020059 | MFCD 118I | Barco N.V. | 2002-04-03 | Traditional | PDF ↗ |
| K020658 | VIATRONIX V3D COLON | Viatronix, Inc. | 2002-03-07 | Abbreviated | PDF ↗ |
| K020483 | ADVANTAGE WORKSTATION 4.1 | GE Medical Systems | 2002-02-28 | Traditional | PDF ↗ |
| K012439 | DENTALEYE 2 DENTAL IMAGE MANAGEMENT SYSTEM | Radco Data AB | 2002-02-06 | Traditional | PDF ↗ |
| K013994 | MODIFICATION TO VIEWSEND MEDICAL | Klt Telecom, Inc. | 2002-02-01 | Special | PDF ↗ |
| K020140 | VOXAR'S CALCIUM SCORING PRODUCT | Voxar Limited | 2002-01-28 | Traditional | PDF ↗ |
| K013922 | CORONIS 3MP MEDICL FLAT PANEL DISPLAY SYSTEM | Barco N.V. | 2002-01-28 | Traditional | PDF ↗ |
| K013841 | 3DFIS, MODEL IES-FL-101 | 3Dsharp, Inc. | 2002-01-17 | Traditional | PDF ↗ |
| K013574 | ACCENT | Confirma, Inc. | 2002-01-15 | Traditional | PDF ↗ |
| K014058 | ENTEGRA PE PERSONAL DIGITAL ASSISTANT | General Electric Medical Systems | 2001-12-21 | Traditional | PDF ↗ |
| K012327 | CSIST DICOM GATEWAY/IMAGE MANAGER | Csist | 2001-12-20 | Traditional | PDF ↗ |
| K013419 | NICOLET ELECTROMAGNETIC NAVIGATION SYSTEM | Nicolet Biomedical | 2001-12-20 | Traditional | PDF ↗ |
| K013098 | KIMAX REMOTE VIEWING STATION | Medical Metrics, Inc. | 2001-12-07 | Traditional | PDF ↗ |
| K013878 | CYBERMED, INC., V-WORKS | Cybermed, Inc. | 2001-12-07 | Traditional | PDF ↗ |
| K013630 | ISITE RADIOLOGY | Stentor, Inc. | 2001-12-05 | Traditional | PDF ↗ |
| K011196 | IQUANTIFY, VERSION 1.0 | Insightful Corporation | 2001-11-08 | Traditional | PDF ↗ |
| K012844 | MAROSIS PACS | Marotech, Inc. | 2001-11-08 | Traditional | PDF ↗ |
| K012779 | ICONNECTION 3D | Hinnovation, Inc. | 2001-11-02 | Traditional | PDF ↗ |
| K012563 | DEEP GRAY | Cortechs Labs, Inc. | 2001-11-02 | Abbreviated | PDF ↗ |
| K012475 | CAAS II QVA | Pie Medical Imaging BV | 2001-10-24 | Traditional | PDF ↗ |
| K012290 | RAPIDIA | 3D Med Co., Ltd. | 2001-09-28 | Traditional | PDF ↗ |
| K012093 | AETMED IMAGE PROCESSING SOFTWARE | Aetmed, S.P.A. | 2001-09-21 | Traditional | PDF ↗ |
| K012086 | AQUARIUSNET SERVER | Terarecon,Inc. | 2001-09-13 | Traditional | PDF ↗ |
| K011694 | VIEWSTATION | Impac Medical Systems, Inc. | 2001-08-29 | Traditional | PDF ↗ |
| K012155 | KODAK RADIATION ONCOLOGY SOFTWARE/ FOR ACR SYSTEMS | Eastman Kodak Company | 2001-08-10 | Special | PDF ↗ |
| K012099 | MONOCHROME PERFECTLY FLAT PANEL DISPLAYS, ME SERIES | Totoku Electric Co., Ltd. | 2001-07-31 | Traditional | PDF ↗ |
| K011582 | QCU ANALYTICAL SOFTWARE PACKAGE | Medis Medical Imaging Systems BV | 2001-07-31 | Traditional | PDF ↗ |
| K012211 | EFILM WORKSTATION | Efilm Medical, Inc. | 2001-07-31 | Traditional | PDF ↗ |
| K012097 | VORTEX | Ultravisual Medical Systems | 2001-07-12 | Traditional | PDF ↗ |
| K012072 | VOXAR VC, MODEL 1.0 | Voxar Limited | 2001-07-12 | Traditional | PDF ↗ |
| K011173 | TELEPAX | Imed Systems & Consulting, LLC | 2001-07-11 | Abbreviated | PDF ↗ |
| K010938 | SYNGO MULTIMODALITY WORKSTATION | Siemens Medical Solutions USA, Inc. | 2001-06-26 | Traditional | PDF ↗ |
| K002911 | XSCAN32 TELERADIOLOGY SOFTWARE | Radiographic Digital Imaging, Inc. | 2001-06-07 | Traditional | PDF ↗ |
| K010763 | GOODNET | Goodman Co., Ltd. | 2001-05-25 | Traditional | PDF ↗ |
| K011142 | AQUARIUS WORKSTATION | Terarecon,Inc. | 2001-05-08 | Traditional | PDF ↗ |
| K010259 | MEDIFACE PACS | Mediface Co., Ltd. | 2001-04-26 | Traditional | PDF ↗ |
| K010726 | MODIFICATION TO MIRAGE | Segami Corp., Inc. | 2001-04-26 | Traditional | PDF ↗ |
| K010271 | THINKINGNET | Thinking Systems Corp. | 2001-04-03 | Traditional | PDF ↗ |
| K010571 | ADC QS/IPD WORKSTATION | Agfa Corp. | 2001-03-28 | Special | PDF ↗ |
| K002789 | MEDEVIEW SYSTEM | Medeview.Com | 2001-03-21 | Traditional | PDF ↗ |
| K010058 | IMAGE IV DICOM IMAGE ARCHIVAL PACS NETWORK | Witt Biomedical Corporation | 2001-03-21 | Traditional | PDF ↗ |
| K003746 | 3D-DOCTOR | Able Software Corp. | 2001-03-13 | Traditional | PDF ↗ |
| K003762 | ALI 3D TOOL MODULE FOR MEDICAL IMAGES | A.L.I. Technologies, Inc. | 2001-02-28 | Traditional | PDF ↗ |
| K010336 | ADVANTAGE WINDOWS CT/PET FUSION | Ge Medical Systems, Inc. | 2001-02-16 | Traditional | PDF ↗ |
| K003607 | ONYX-RAD TELEMEDICINE PACS | Viztek, Inc. | 2001-02-15 | Traditional | PDF ↗ |
| K003510 | INSTATRAK SYSTEM WITH FLUOROCAT, MODEL IT3500 | Visualization Technology, Inc. | 2001-02-12 | Traditional | PDF ↗ |
| K003437 | ODYSSEY LX, MODEL 211320 | Philips Medical Systems (Cleveland), Inc. | 2001-02-02 | Traditional | PDF ↗ |
| K003459 | PHILIPS EASY VISION FAMILY WORKSTATION OPTION MR QUANTITATIVE FLOW | Philips Medical Systems North America, Inc. | 2001-01-22 | Traditional | PDF ↗ |
| K003688 | VIEW READING STATION | Electromed Intl., Ltd. | 2001-01-22 | Abbreviated | PDF ↗ |
| K003484 | NETRA WORKSTATION AND NETRAMD SOFTWARE | Scimage, Inc. | 2001-01-19 | Traditional | PDF ↗ |
| K002942 | PHILIPS EASY VISION FAMILY WORKSTATION OPTION CARDIRAC SCORING | Philips Medical Systems North America, Inc. | 2000-12-19 | Traditional | PDF ↗ |
| K001550 | EBT ULTRAFAST CT SCANNER SYSTEM; C-100, C-150, C-150LXP OR C-150XP SCANNER SYSTEMS; ELECTRON BEAM SCANNER SYSTEM; ELECTR | Imatron, Inc. | 2000-12-11 | Traditional | PDF ↗ |
| K002782 | HERMES HD AQ ACQUISITION STATION AND HERMES WORKSTATION | Nuclear Diagnostics AB | 2000-12-05 | Traditional | PDF ↗ |
| K002894 | MEDIPRIME | Algotec Systems, Ltd. | 2000-12-05 | Traditional | PDF ↗ |
| K001947 | T.I.M.S., VERSION 2.00 | Total Medical Information Management Systems, Inc. | 2000-11-22 | Traditional | PDF ↗ |
| K002597 | CN ACQUISITION STATION | Cardionow, Inc. | 2000-11-17 | Traditional | PDF ↗ |
| K002780 | VIATRONIX VISUALIZATION SYSTEM (VVS) | Viatronix, Inc. | 2000-11-17 | Traditional | PDF ↗ |
| K002724 | NUMALINK | Numa, Inc. | 2000-11-17 | Traditional | PDF ↗ |
| K002590 | CEDARA CARDIOLOGY VIEWER, CARDIOLOGY ARCHIVE VIEWER, CARDIOLOGY CD VIEWER | Cedara Software Corp. | 2000-10-31 | Traditional | PDF ↗ |
Product code LLZ · Class II · Radiology. Data: openFDA.