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 14 of 23
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K093423 | LUNGPOINT PROCEDURE PLANNING | Broncus Technologies, Inc. | 2009-11-17 | Special | PDF ↗ |
| K092741 | COLOR LCD MONITOR, MODEL RADIFORCE MX241W | Eizo Nanao Corporation | 2009-11-10 | Special | PDF ↗ |
| K092954 | CADSTREAM VERSION 5 | Confirma, Inc. | 2009-11-06 | Special | PDF ↗ |
| K093234 | INTEGRATED REGISTRATION | GE Medical Systems SCS | 2009-10-30 | Traditional | PDF ↗ |
| K092581 | MITS DICOM GATEWAY AND IMAGE MANAGER | Mitsmed Medical Instrument Technology Co., Ltd. | 2009-10-30 | Traditional | PDF ↗ |
| K092204 | PMD VIEWER | Spencer Technologies | 2009-10-08 | Traditional | PDF ↗ |
| K092949 | IMAGEGRID RADIOLOGY VIEWER SYSTEM | Candelis, Inc. | 2009-10-08 | Traditional | PDF ↗ |
| K092067 | ABVS WORKPLACE | Siemens AG Medical Solutions | 2009-09-18 | Traditional | PDF ↗ |
| K092134 | STAT PACS PICTURE ARCHIVING & COMMUNICATION SYSTEM (PACS) | Statrad, LLC | 2009-09-15 | Traditional | PDF ↗ |
| K092519 | SYNGO.X | Siemens AG Medical Solutions | 2009-08-27 | Traditional | PDF ↗ |
| K092102 | NORDICBRAINEX SOFTWARE, VERSION 1.0 | Nordicimaginglab AS | 2009-08-25 | Traditional | PDF ↗ |
| K092235 | BEYONDIMAGE WORKSTATION | Neusoft Medical Systems Co., Ltd. | 2009-08-06 | Traditional | PDF ↗ |
| K092081 | QXLINK | Vieworks Co., Ltd. | 2009-07-21 | Traditional | PDF ↗ |
| K091274 | CORONIS 5MP HD, MODEL MDMG 5121 | Barco N.V. | 2009-07-14 | Special | PDF ↗ |
| K091687 | PACSMATE, MODEL MMD-4300C/MMD-4300CX | Iei Technology Corp. | 2009-07-07 | Traditional | PDF ↗ |
| K083658 | PACS PLUS 5TH EDITION | Medical Standard Co., Ltd. | 2009-07-07 | Traditional | PDF ↗ |
| K091001 | MYRIAN 1.4 | Intrasense | 2009-06-29 | Traditional | PDF ↗ |
| K091262 | MR CARDIAC FUNCTION ANALYSIS | Ziosoft, Inc. | 2009-06-29 | Traditional | PDF ↗ |
| K090668 | VISION TOOLS | Millensys | 2009-06-23 | Traditional | PDF ↗ |
| K083520 | INTELEPACS, MODEL VERSION 3.X.X | Intelerad Medical Systems Incorporated | 2009-06-23 | Traditional | PDF ↗ |
| K091032 | CERNER PROVISION WORKSTATION (VERSION 2.5) | Cerner Corp. | 2009-06-22 | Traditional | PDF ↗ |
| K090431 | DEXIS SOFTWARE | Dexis, LLC | 2009-06-22 | Traditional | PDF ↗ |
| K090546 | MODIFICATION TO NORDICICE SOFTWARE | Nordicimaginglab AS | 2009-06-08 | Traditional | PDF ↗ |
| K091498 | VITREA ENDOVASCULAR STENT PLANNING SOFTWARE | Vital Images, Inc. | 2009-06-05 | Traditional | PDF ↗ |
| K091368 | R2 DIGITALNOW HD(DIGITALNOW HD) | Hologic, Inc. | 2009-06-04 | Traditional | PDF ↗ |
| K090461 | IMAGE-ARENA 4.0 AND IA APPLICATIONS 2D CARDIAC PERFORMANCE ANALYSIS 1.0 | Tomtec Imaging Systems GmbH | 2009-05-22 | Traditional | PDF ↗ |
| K090155 | CAAS MR FLOW 1.0 | Pie Medical Imaging BV | 2009-05-22 | Traditional | PDF ↗ |
| K091373 | SYNGO TRUED | Siemens Medical Solutions USA, Inc. | 2009-05-20 | Traditional | PDF ↗ |
| K083327 | SYNGOCIRCULATION DYNAMICPET, VERSION 1.0 | Siemens Medical Solutions USA, Inc. | 2009-05-18 | Traditional | PDF ↗ |
| K091286 | SYNGO US WORKPLACE | Siemens Medical Solutions USA, Inc. | 2009-05-15 | Traditional | PDF ↗ |
| K090833 | SEGMENT | Medviso | 2009-05-12 | Traditional | PDF ↗ |
| K091172 | NIO 2MP (MDNG-2121) | Barco N.V. | 2009-05-05 | Traditional | PDF ↗ |
| K091160 | LUNGPOINT VIRTUAL BRONCHOSCOPIC NAVIGATION VBN SYSTEM | Broncus Technologies, Inc. | 2009-05-05 | Special | PDF ↗ |
| K090603 | BARCO 5MP MAMMO, MODEL MDMG-5221 | Barco N.V. | 2009-04-22 | Traditional | PDF ↗ |
| K090607 | BLUE SKY BIO PLAN, VERSION .38 | Blue Sky Bio, LLC | 2009-04-22 | Traditional | PDF ↗ |
| K090732 | NIO COLOR 3MP AND MDNC-3121 | Barco N.V. | 2009-04-20 | Special | PDF ↗ |
| K083910 | VIDISTAR PACS & DICOM VIEWER SOFTWARE SERVER SOFTWARE SYSTEM, HEART VIEW, STANDALONE VIEWER | Vidistar, LLC | 2009-04-15 | Traditional | PDF ↗ |
| K090218 | MD213MC 21.3 DIAGNOSTIC IMAGING LCD MONITOR MODEL, L218TJ | Nec Display Solutions , Ltd. | 2009-04-15 | Traditional | PDF ↗ |
| K090215 | MD213MG 21.3 DIAGNOSTIC IMAGING LCD MONITOR - L218TL | Nec Display Solutions , Ltd. | 2009-04-15 | Traditional | PDF ↗ |
| K083446 | CARDIAC FUNCTION ANALYSIS, CALCIUM SCORING | Ziosoft, Inc. | 2009-03-31 | Traditional | PDF ↗ |
| K090223 | ICAD BREAST INTERVENTIONAL PLANNING SOFTWARE, MODEL D70024 | Icad, Inc. | 2009-03-31 | Traditional | PDF ↗ |
| K090649 | VRAD PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM SOFTWARE | Virtual Radiologic Corporation | 2009-03-27 | Traditional | PDF ↗ |
| K081168 | BRIT PACS SYSTEMS | Brit Systems, Inc. | 2009-03-23 | Traditional | PDF ↗ |
| K090481 | DEMASQ IMAGING SPFTWARE DEVICE | Demasq Limited | 2009-03-19 | Traditional | PDF ↗ |
| K090552 | UROCARE | Neusoft Medical Systems Co., Ltd. | 2009-03-16 | Traditional | PDF ↗ |
| K090095 | LUNGPOINT VIRTUAL BRONCHOSCOPIC NAVIGATION VBN SYSTEM | Broncus Technologies, Inc. | 2009-03-13 | Traditional | PDF ↗ |
| K090295 | BODYVIZ, MODEL 100 | Visual Medical Solutions, LLC | 2009-03-04 | Traditional | PDF ↗ |
| K083182 | DATACOM DC PACS | Datacom Technology Corp. | 2009-03-04 | Traditional | PDF ↗ |
| K083691 | BONEVUE | Micromri, Inc. | 2009-02-25 | Traditional | PDF ↗ |
| K082623 | VISIX IMAGING | Televere Systems | 2009-02-25 | Traditional | PDF ↗ |
| K082693 | RESOLUTIONMD, RELEASE 2.1 | Calgary Scientific, Inc. | 2009-02-23 | Traditional | PDF ↗ |
| K083491 | NEUROSCAPE | Olea Medical | 2009-02-19 | Traditional | PDF ↗ |
| K083740 | MAMMODIAGNOST VU | Philips Medical Systems Nederland B.V. | 2009-02-13 | Traditional | PDF ↗ |
| K090119 | SICAT IMPLANT | Sicat GmbH & Co. KG | 2009-02-05 | Traditional | PDF ↗ |
| K081556 | CADSTREAM, VERSION 5.0 | Confirma, Inc. | 2009-02-02 | Traditional | PDF ↗ |
| K083618 | PACS SCAN | Pacsgear, Inc. | 2009-01-28 | Traditional | PDF ↗ |
| K090045 | COLOR LCD MONITOR, RADIFORCE RX320 | Eizo Nanao Corporation | 2009-01-28 | Special | PDF ↗ |
| K083149 | ARTERIAL HEALTH PACKAGE (AHP) SOFTWARE | Siemens Medical Solutions USA, Inc. | 2009-01-14 | Traditional | PDF ↗ |
| K083916 | LCD3090WQXI OR MD304MC 29.8 INCH DIAGNOSTIC IMAGING LCD MONITOR, MODEL L307TD | Nec Display Solutions , Ltd. | 2009-01-14 | Traditional | PDF ↗ |
| K083907 | MD212MC 21.3 DIAGNOSTIC IMAGING LCD MONITOR-L217TG | Nec Display Solutions , Ltd. | 2009-01-13 | Traditional | PDF ↗ |
| K082808 | IMAGESVR PACS | Jaguar Technology Limited | 2009-01-09 | Traditional | PDF ↗ |
| K083332 | MD21M 21.3 DIAGNOSTIC IMAGING LCD MONITOR, MODEL L218TK | Nec Display Solutions , Ltd. | 2009-01-09 | Traditional | PDF ↗ |
| K082526 | CARDIO VUE QUANTITATIVE ANALYSIS (CVQ) | Mri Cardiac Services, Incorporated | 2009-01-05 | Traditional | PDF ↗ |
| K083673 | CARESTREAM PACS, MODEL CARESTREAM PACS VII | Carestream Health, Inc. | 2008-12-30 | Traditional | PDF ↗ |
| K083348 | IMAGE-ARENA APPLICATIONS | Tomtec Imaging Systems GmbH | 2008-12-23 | Traditional | PDF ↗ |
| K083084 | CT BRAIN PERFUSION FOR ZIOSTATION | Ziosoft, Inc. | 2008-12-19 | Traditional | PDF ↗ |
| K083555 | PICTURE ARCHIVING AND COMMUNICATION SYSTEM (PACS), PETAVISION | Emsoma Co., Ltd. | 2008-12-16 | Traditional | PDF ↗ |
| K082269 | VISAGE PACS, VERSION 6.0/CS 3.1 | Visage Imaging, Inc. | 2008-12-12 | Traditional | PDF ↗ |
| K082607 | MRI-PLAQUE VIEW, VERSION 1.1.2003 | Vpdiagnostics, Inc. | 2008-12-05 | Traditional | PDF ↗ |
| K082441 | NORDICICE SOFTWARE | Nordicimaginglab AS | 2008-11-21 | Traditional | PDF ↗ |
| K082990 | INFINITT XELIS | Infinitt Co., Ltd. | 2008-11-20 | Traditional | PDF ↗ |
| K082240 | SNTRYPACS | Qstar Technologies, Inc. | 2008-11-20 | Traditional | PDF ↗ |
| K082628 | CMR42 CARDIAC MRI IMAGING SYSTEM, 2.1.23 | Circle Cardiovascular Imaging, Inc. | 2008-11-20 | Traditional | PDF ↗ |
| K083018 | CENTRICITY PACS WEB DIAGNOSTIC | Ge Healthcare Dynamic Imaging Solutions | 2008-11-14 | Special | PDF ↗ |
| K082430 | SYNGO IMAGING XS | Siemens AG Medical Solutions | 2008-11-14 | Traditional | PDF ↗ |
| K082706 | INFINITT CARDIOLOGY PACS | Infinitt Co., Ltd. | 2008-11-06 | Traditional | PDF ↗ |
| K082493 | MEDICAL DISPLAY, MD205MG-1 | Nec Display Solutions , Ltd. | 2008-10-23 | Traditional | PDF ↗ |
| K082135 | SHOWCASE | Trillium Technology, Inc. | 2008-10-21 | Traditional | PDF ↗ |
| K082336 | XR-EXPRESS | New Mexico Software, Inc. | 2008-10-15 | Traditional | PDF ↗ |
| K082684 | 4D VIEWER RADIOLOGY, MODEL USWP-100A | Toshiba America Medical Systems, In.C | 2008-10-14 | Traditional | PDF ↗ |
| K082663 | COLOR LCD MONITOR | Eizo Nanao Corporation | 2008-10-06 | Special | PDF ↗ |
| K082510 | IMAGE-ARENA APPLICATIONS, MODEL IMAGE-ARENA VA PLATFORM 1.0, 4D LV-ANALYSIS 2.5, 4D LV-ANALYSIS MR 1.0 | Tomtec Imaging Systems GmbH | 2008-10-01 | Traditional | PDF ↗ |
| K081987 | UNISYN IMAGE FUSION, VERSION 1.0 | Convergent Imaging Solutions | 2008-09-26 | Traditional | PDF ↗ |
| K081985 | AW SERVER | Ge Medical Systems, LLC | 2008-09-25 | Traditional | PDF ↗ |
| K082596 | ULTRAEXTEND USWS-900A | Toshiba America Medical Systems, In.C | 2008-09-23 | Traditional | PDF ↗ |
| K082228 | PLANISIGHT LINASYS | Pathfinder Therapeutics, Inc. | 2008-09-22 | Traditional | PDF ↗ |
| K081948 | RAYPAX SYSTEM | Raypax, Inc. | 2008-09-19 | Traditional | PDF ↗ |
| K081792 | SPY ANALYSIS TOOLKIT, MODEL SA9000 | Novadaq Technologies, Inc. | 2008-09-17 | Traditional | PDF ↗ |
| K082386 | INREACH PLANNING LAPTOP | Superdimension, Ltd. | 2008-09-16 | Special | PDF ↗ |
| K082483 | QUANTRA | Hologic, Inc. | 2008-09-12 | Traditional | PDF ↗ |
| K081945 | 21.3-INCH (54CM) MONOCHROME LCD MONITOR MS21I2 (MDL2127A) | Totoku Electric Co., Ltd. | 2008-09-12 | Traditional | PDF ↗ |
| K081656 | VISUALASE THERMAL THERAPY SYSTEM | Biotex, Inc. | 2008-09-10 | Traditional | PDF ↗ |
| K082496 | PACSMATE MMD-3213M MONITOR | Iei Technology Corp. | 2008-09-09 | Traditional | PDF ↗ |
| K080196 | Z3D CONTRAST ACUITY | Clario Medical Imaging, Inc. | 2008-09-05 | Traditional | PDF ↗ |
| K081357 | 5MP GRAYSCALE FLAT PANEL DISPLAY, MODEL, 6GF6201-5C$2# (WHERE $ = A-Z AND # = 0-9) | Eizo GmbH | 2008-09-05 | Traditional | PDF ↗ |
| K082144 | AMICAS PACS, VERSION 6.0 | Amicas, Inc. | 2008-09-05 | Traditional | PDF ↗ |
| K082341 | DSA 2000EX | Eigen, LLC | 2008-08-29 | Traditional | PDF ↗ |
| K080529 | STEREOS WORKSTATION | Biospace Med | 2008-08-29 | Traditional | PDF ↗ |
| K081215 | VOLUMINA | Kjaya Medical, LLC | 2008-08-26 | Traditional | PDF ↗ |
| K082318 | CENTRICITY PACS IW | Ge Healthcare Dynamic Imaging Solutions | 2008-08-25 | Special | PDF ↗ |
Product code LLZ · Class II · Radiology. Data: openFDA.