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 16 of 23
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K070713 | IMPLANT LOCATION SOFTWARE-T | Tactile Technologies, Ltd. | 2007-05-02 | Traditional | PDF ↗ |
| K070726 | NIO COLOR 3MP AND MDNC 3120 | Barcoview, Medical Imaging Systems | 2007-05-02 | Traditional | PDF ↗ |
| K063391 | SAPHENEIA CLARITY | Sapheneia Commercial Products AB | 2007-04-26 | Traditional | PDF ↗ |
| K070618 | DICOMPACS, MODEL 5 | Oehm Und Rehbein GmbH | 2007-04-25 | Traditional | PDF ↗ |
| K070606 | VISIO+CD VIEWER# KPSCDVE01 | Keosys Sas | 2007-04-24 | Traditional | PDF ↗ |
| K070954 | PATIENTGALLERY IMAGING SOFTWARE | Raster Builders, Inc. | 2007-04-20 | Traditional | PDF ↗ |
| K070397 | DGSCOPE, RELEASE 1.0 | Segami Corporation | 2007-04-13 | Traditional | PDF ↗ |
| K070683 | MIRAGE CEDARS OPTION | Segami Corporation | 2007-04-12 | Special | PDF ↗ |
| K070803 | INVIVODENTAL | Anatomage, Inc. | 2007-04-06 | Traditional | PDF ↗ |
| K070792 | QLAB QUANTIFICATION | Philips Ultrasound, Inc. | 2007-04-06 | Traditional | PDF ↗ |
| K070796 | CHILI PACS | Chili GmbH | 2007-04-06 | Traditional | PDF ↗ |
| K070394 | CERNER PROVISION WORKSTATION | Cerner Corp. | 2007-03-27 | Traditional | PDF ↗ |
| K070205 | ZIOSTATION | Ziosoft, Inc. | 2007-03-23 | Traditional | PDF ↗ |
| K062621 | NIO 5MP-21 AND MDNG-5121 CB | Barcoview | 2007-03-19 | Traditional | PDF ↗ |
| K070464 | ONDEMAND3D | Cybermed, Inc. | 2007-03-16 | Traditional | PDF ↗ |
| K070370 | 21.3 INCH (54CM) MONOCHROME LCD MONITOR MDL2122A | Totoku Electric Co., Ltd. | 2007-03-09 | Traditional | PDF ↗ |
| K070226 | CARDIOCT | Shina Systems , Ltd. | 2007-03-09 | Traditional | PDF ↗ |
| K070089 | SYNTERMED LIVE | Syntermed, Inc. | 2007-03-02 | Traditional | PDF ↗ |
| K070248 | VELOCITYAIS | Velocity Medical Solutions, LLC | 2007-03-01 | Traditional | PDF ↗ |
| K070322 | SYNGO DYNAMICS, VERSION 6.0 | Siemens Medical Solutions USA, Inc. | 2007-02-27 | Special | PDF ↗ |
| K070131 | RADIFORCE GX220 AND GS220 MONOCHROME LCD MONITORS | Eizo Nanao Corporation | 2007-02-15 | Special | PDF ↗ |
| K070244 | AEGIS | Sentinelle Medical, Inc. | 2007-02-09 | Traditional | PDF ↗ |
| K070122 | MONOCHROME LCD MONITOR, MODEL RADIFORCE GX320 | Eizo Nanao Corporation | 2007-02-08 | Special | PDF ↗ |
| K063730 | DEXTROSCOPE, MODEL MK10; DEXTROBEAM, MODEL MK3, MK4; RADIODEXTER, MODEL 1.0 | Volume Interactions Pte, Ltd. | 2007-01-31 | Special | PDF ↗ |
| K063846 | EIGEN DSA 2000 | Eigen | 2007-01-26 | Special | PDF ↗ |
| K063294 | TOPACS | Radiological Specialists, Inc. | 2007-01-24 | Traditional | PDF ↗ |
| K070080 | INTELEPACS | Intelerad Medical Systems, Inc. | 2007-01-24 | Traditional | PDF ↗ |
| K063548 | COR ANALYZER 1, VERSION 1.4 | Rcadia Medical Imaging , Ltd. | 2007-01-22 | Traditional | PDF ↗ |
| K063439 | MEDICAL IMAGE MANAGEMENT DEVICES FOR VISION TOOLS | Mtd, Inc. | 2007-01-22 | Traditional | PDF ↗ |
| K063539 | NORDIC IMAGE CONTROL AND EVALUATION (NICE) SOFTWARE, VERSION 2.1 | Nordicicemedical AS | 2007-01-17 | Traditional | PDF ↗ |
| K063826 | SYNGO MI APPLICATIONS 2007A | Siemens Medical Solutions USA, Inc. | 2007-01-12 | Special | PDF ↗ |
| K063470 | AYCAN WORKSTATION OSIRIX | Aycan Digitalsysteme GmbH | 2007-01-05 | Traditional | PDF ↗ |
| K063781 | PHILIPS XD-S DIRECT RADIOGRAPHY WORKSTATION/PACKAGE | Philips Medical Systems North America Co. | 2007-01-05 | Traditional | PDF ↗ |
| K062905 | NIO FUSION 4MP; MDNC 4130 | Barcoview | 2006-12-29 | Traditional | PDF ↗ |
| K063628 | CENTRICITY RADIOLOGY RA600, CARDIOLOGY CA1000 AND DIGITAL HARDCOPY | Ge Healthcare Integrated IT Solutions | 2006-12-26 | Traditional | PDF ↗ |
| K063579 | 2MP MEDICAL COLOR REFERENCE DISPLAY, MODEL MDC2130-2HC | Chi Lin Technology Co., Ltd. | 2006-12-14 | Traditional | PDF ↗ |
| K063337 | OPAL-RAD | Viztek, Inc. | 2006-12-12 | Traditional | PDF ↗ |
| K063505 | VISUALASE ENVISION SOFTWARE SYSTEM | Biotex, Inc. | 2006-12-12 | Traditional | PDF ↗ |
| K063253 | RCHIVE PACS | Sobha Renaissance Information Technology Pvt, Ltd. | 2006-12-12 | Traditional | PDF ↗ |
| K063221 | MEDWEB ADVANCED 3D WEB PACS | Nexsys Electronics, Inc. | 2006-12-12 | Traditional | PDF ↗ |
| K063392 | IMCO-STAT | Imco Technologies | 2006-12-12 | Traditional | PDF ↗ |
| K063200 | 20.1-INCH (51CM) COLOR LCD MONITOR CDL2010A (CCL204) | Totoku Electric Co., Ltd. | 2006-12-07 | Traditional | PDF ↗ |
| K063153 | NOVAPACS | Novarad Corp. | 2006-12-07 | Traditional | PDF ↗ |
| K063199 | 21.3-INCH (54CM) COLOR LCD MONITOR CDL2120A (CCL252I2) | Totoku Electric Co., Ltd. | 2006-12-04 | Traditional | PDF ↗ |
| K063197 | 21.3 INCH (54CM) MONOCHROME LCD MONITOR MDL2118A (ME355I2) | Totoku Electric Co., Ltd. | 2006-11-30 | Traditional | PDF ↗ |
| K063198 | 21.3-INCH (54CM) MONOCHROME LCD MONITOR MDL2121A (ME253I2) | Totoku Electric Co., Ltd. | 2006-11-30 | Traditional | PDF ↗ |
| K063188 | DEL-IMS | Del Medical Imaging Corp. | 2006-11-30 | Traditional | PDF ↗ |
| K063344 | CAAS QCA 3D | Pie Medical Imaging BV | 2006-11-28 | Special | PDF ↗ |
| K063327 | ORTHOVIEW | Merdian Technique, Ltd. | 2006-11-22 | Traditional | PDF ↗ |
| K062985 | IVUS ENHANCER | Indec Systems, Inc. | 2006-11-22 | Traditional | PDF ↗ |
| K062237 | CADI, VERSION 4 | Synca Marketing, Inc. | 2006-11-20 | Traditional | PDF ↗ |
| K062131 | NIO 5MP-M-21 (NIO 5MP MAMMO); MDNG-5121 BB | Barcoview | 2006-11-17 | Traditional | PDF ↗ |
| K063289 | 2MP MEDICAL MONOCHROME REFERENCE DISPLAY, MODEL MDM2130-2NC | Chi Lin Technology Co., Ltd. | 2006-11-16 | Traditional | PDF ↗ |
| K061696 | IQQA-LIVER SOFTWARE | Edda Technology, Inc. | 2006-11-13 | Traditional | PDF ↗ |
| K063120 | COLOR LCD MONITOR, RADIFORCE, MODEL RX210 | Eizo Nanao Corporation | 2006-11-09 | Special | PDF ↗ |
| K063266 | 3MP MEDICAL MONOCHROME REFERENCE DISPLAY, MODEL MDM2130-3NC | Chi Lin Technology Co., Ltd. | 2006-11-09 | Traditional | PDF ↗ |
| K063267 | ISITE PACS, V 4. X | Stentor Inc., A Philips Medical Systems Co. | 2006-11-09 | Traditional | PDF ↗ |
| K063093 | SECTRA WORKSTATION, VERSION 11.1 | Sectra Imtec AB | 2006-11-07 | Special | PDF ↗ |
| K062757 | XERON PACS | Xeron Healthcare Corp. | 2006-11-07 | Traditional | PDF ↗ |
| K063031 | PRISM VIEW, MODEL | Kyron Clinical Imaging, Inc. | 2006-11-02 | Special | PDF ↗ |
| K063006 | GE LOGIQ WORKS | General Electric Co. | 2006-11-02 | Special | PDF ↗ |
| K062598 | IMT.LAB SOFTWARE | Esaote Europe B.V. | 2006-10-31 | Traditional | PDF ↗ |
| K062743 | UNISIGHT MAMMOGRAPHY VIEWER, MODEL 4.0 | Electronic Business Machine Co., Ltd. (Ebm) | 2006-10-31 | Traditional | PDF ↗ |
| K063107 | 3DNET SUITE | Biotronics3D, Ltd. | 2006-10-27 | Traditional | PDF ↗ |
| K060836 | VISTADENT OC - VERSION 4 | Dentsply Intl., Inc. | 2006-10-27 | Special | PDF ↗ |
| K062477 | AMICAS VISION SERIES PACS, MODEL 4.3 | Amicas, Inc. | 2006-10-27 | Traditional | PDF ↗ |
| K062490 | VISAGE PACS/CS, RELEASE VERSION 4.1 | Mercury Computer Systems, Inc. | 2006-10-27 | Traditional | PDF ↗ |
| K063037 | CENTARISONE RIS/PACS | Centarisone, LLC | 2006-10-18 | Traditional | PDF ↗ |
| K062054 | 5 MEGAPIXEL MONOCHROME LCD MONITOR, RADIFORCE GS510 | Eizo Nanao Corporation | 2006-10-06 | Special | PDF ↗ |
| K062031 | CHASE CARDIAC ANALYSIS SYSTEM | Chase Medical, LP | 2006-09-27 | Traditional | PDF ↗ |
| K062164 | RESOLUTIONMD, VERSION 1.3 | Calgary Scientific, Inc. | 2006-09-22 | Traditional | PDF ↗ |
| K062163 | MIMVIEWER | Mimvista Corp. | 2006-09-22 | Traditional | PDF ↗ |
| K062650 | EP NAVIGATOR SOFTWARE | Philips Medical Systems | 2006-09-21 | Traditional | PDF ↗ |
| K062488 | IQ-SYSTEM PACS SYSTEM | Image Information Systems, Ltd. | 2006-09-19 | Traditional | PDF ↗ |
| K061972 | CONNECT IMAGING PACS | Connect Imaging, Inc. | 2006-09-18 | Abbreviated | PDF ↗ |
| K061532 | GENTLE COLON (REVISION 2.0) | Rendoscopy, Inc. | 2006-09-18 | Traditional | PDF ↗ |
| K062229 | CTC WORKSTATION, MODEL 2200 | Medical Diagnostic Technologies, Inc. | 2006-09-11 | Traditional | PDF ↗ |
| K062062 | VOYAGER PACS SYSTEM | Voyager Imaging | 2006-09-11 | Traditional | PDF ↗ |
| K062059 | AIE REGION OF INTEREST IMAGE ENHANCEMENT | Advanced Image Enhancement | 2006-09-06 | Traditional | PDF ↗ |
| K061995 | XCELERA | Philips Medical Systems North America Co. | 2006-09-06 | Traditional | PDF ↗ |
| K061961 | ART LAB SOFTWARE | Pie Medical | 2006-09-06 | Traditional | PDF ↗ |
| K061928 | CORONIS COLOR 2MP AND MDCC 2121 | Barcoview | 2006-09-05 | Traditional | PDF ↗ |
| K061927 | CORONIS COLOR 3MP AND MDCC 3120-DL | Barcoview | 2006-09-05 | Traditional | PDF ↗ |
| K061924 | CORONIS 3MP AND MDCG 3120-CB | Barcoview | 2006-09-05 | Traditional | PDF ↗ |
| K061920 | NOVAPACS, NOVAVIEW, NOVACARDIO, NOVAQC AND NOVAER | Novarad Corp. | 2006-08-21 | Traditional | PDF ↗ |
| K062328 | VITREAACCESS, VERSION 1.0 | Vital Images, Inc. | 2006-08-21 | Traditional | PDF ↗ |
| K061926 | CORONIS 2MP AND MDCG 2121 - CB | Barcoview | 2006-08-18 | Traditional | PDF ↗ |
| K062107 | SECURVIEW DX DIAGNOSTIC WORKSTATION, MODELS SV-0001, SV-0002 AND SV-0003 | Hologic, Inc. | 2006-08-18 | Special | PDF ↗ |
| K061855 | NEUROQUANT | Cortechs Labs, Inc. | 2006-08-10 | Traditional | PDF ↗ |
| K062154 | VITAL CONNECT 4.0 | Vital Images, Inc. | 2006-08-10 | Abbreviated | PDF ↗ |
| K062053 | MONOCHROME LCD MONITOR, RADIFORCE, GS320 | Eizo Nanao Corporation | 2006-08-07 | Special | PDF ↗ |
| K061964 | SYNGO MULTIMODALITY WORKPLACE | Siemens AG Medical Solutions | 2006-07-27 | Traditional | PDF ↗ |
| K061947 | 21.3 INCH MONOCHROME LCD MONITOR | Nec Display Solutions , Ltd. | 2006-07-25 | Traditional | PDF ↗ |
| K061421 | ERAD PACS | Erad, Inc. | 2006-07-25 | Traditional | PDF ↗ |
| K061418 | QUANTIVA | Tomographix IP , Ltd. | 2006-07-21 | Traditional | PDF ↗ |
| K061447 | 5M MONOCHROME DIGITAL MAMMOGRAPHY LCD MONITOR MDL2116A (ME551I2) | Totoku Electric Co., Ltd. | 2006-07-21 | Traditional | PDF ↗ |
| K061671 | SYNGO TRUED, MODEL VC10A | Siemens Medical Solutions | 2006-06-29 | Traditional | PDF ↗ |
| K061672 | SYNAPSE MIP/MPR IMAGE VISUALIZATION SOFTWARE OBLIQUUS | Fujifilm Medical Systems U.S.A, Inc. | 2006-06-29 | Traditional | PDF ↗ |
| K061624 | VITREA, VERSION 3.9 | Vital Images, Inc. | 2006-06-27 | Traditional | PDF ↗ |
| K061160 | M-VU CAD STATION | Vucomp, Inc. | 2006-06-09 | Traditional | PDF ↗ |
Product code LLZ · Class II · Radiology. Data: openFDA.