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 15 of 23
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K081672 | C-INSIGHT | Mazor Surgical Technologies , Ltd. | 2008-08-15 | Traditional | PDF ↗ |
| K081752 | EDGE PACS | Ashva Technologies, Pvt., Ltd. | 2008-08-06 | Traditional | PDF ↗ |
| K082041 | FIATLUX VISUALIZE | Fiatlux Imaging, Inc. | 2008-08-01 | Traditional | PDF ↗ |
| K081630 | MAMMO WORKSTATION | Image Diagnost International GmbH | 2008-07-29 | Abbreviated | PDF ↗ |
| K081976 | IMPAX MA3000 DIAGNOSTIC PACS WORKSTATION | Agfa Healthcare Corporation | 2008-07-28 | Traditional | PDF ↗ |
| K081512 | STEALTHVIZ ADVANCED PLANNING APPLICATION WITH STEALTHDTI PACKAGE | Medtronic Navigation, Inc. | 2008-07-18 | Traditional | PDF ↗ |
| K081402 | SIMPLANT ORTHO ; VISTADENT 3D | Materialise Dental NV | 2008-07-18 | Traditional | PDF ↗ |
| K080905 | QUANTUM/ CANON CXDI INTEGRATION SYSTEM, MODEL QG-DIG-CXDI | Quantum Medical Imaging, LLC | 2008-07-16 | Traditional | PDF ↗ |
| K081843 | ULTRASOUND DATA ANALYSIS SYSTEM, MODEL DAS-RS1 | Aloka Co., Ltd. | 2008-07-15 | Traditional | PDF ↗ |
| K081734 | SYNGO IMAGING (VERSION V31) | Siemens AG Medical Solutions | 2008-07-03 | Traditional | PDF ↗ |
| K081076 | VELOCITYAIS, VELOCITY AI, VELOCITYVX, VELOCITYRT, V-RESPONSE | Velocity Medical Solutions, LLC | 2008-06-20 | Special | PDF ↗ |
| K081262 | DC NEURO | Invivo Corporation | 2008-06-17 | Traditional | PDF ↗ |
| K081469 | SECTRA WORKSTATION, IDS7 VERSION 11.3, IDS5 VERSION 11.1 P2 | Sectra Imtec AB | 2008-06-12 | Special | PDF ↗ |
| K081304 | ALZ WEB PACS, VERSION 1.0 | Alz, Inc. | 2008-06-11 | Traditional | PDF ↗ |
| K081242 | 21.3 INCH (53CM) MONOCHROME DIGITAL MAMMOGRAPHY LCD MONITOR MS51I2, (MDL2123A) | Tokotu Electric Co., Ltd. | 2008-06-11 | Traditional | PDF ↗ |
| K081056 | 21.3 (54CM) 3M COLOR LCD MONITOR CCL354I2 (CDL2126A) | Totoku Electric Co., Ltd. | 2008-06-04 | Traditional | PDF ↗ |
| K081308 | FUJIFILM FCR VIEW, MODEL CR-VW674 | Fujifilm Medical Systems U.S.A, Inc. | 2008-06-04 | Special | PDF ↗ |
| K081055 | 21.3 (54CM) 2M COLOR LCD MONITOR CCL254I2 (CDL2125A) | Totoku Electric Co., Ltd. | 2008-06-04 | Traditional | PDF ↗ |
| K080952 | 15-INCH (38 CM) COLOR LCD MONITOR CDL1576A | Totoku Electric Co., Ltd. | 2008-05-29 | Traditional | PDF ↗ |
| K080951 | 19-INCH (48CM) 1.3M COLOR LCD MONITOR CDL1909A | Totoku Electric Co., Ltd. | 2008-05-29 | Traditional | PDF ↗ |
| K081347 | ILUMA VISION | Imtec Corp. | 2008-05-28 | Traditional | PDF ↗ |
| K072258 | BI-RADS COMPANION | Almen Laboratories, Inc. | 2008-05-16 | Traditional | PDF ↗ |
| K081109 | CORONIS 5MP MAMMO SL, MODEL MDMG 6121 | Barcoview, Medical Imaging Systems | 2008-05-02 | Traditional | PDF ↗ |
| K081093 | 3-D IMAGING WORKSTATION | Eigen, LLC | 2008-05-01 | Traditional | PDF ↗ |
| K080890 | SMARTSPOT PRIMAX | Cmt Medical Technologies, Ltd. | 2008-04-29 | Special | PDF ↗ |
| K081018 | SYNGO DYNAMICS VERSION 7.0 | Siemens Medical Solutions | 2008-04-25 | Special | PDF ↗ |
| K073358 | LUMIMED SERIES 5MP DIGITAL FLAT PANEL DISPLAY SYSTEM, MODEL MM50/MM50A | Heeyoung Co., Ltd. | 2008-04-25 | Traditional | PDF ↗ |
| K072728 | SYNGO MULTIMODALITY WORKPLACE | Siemens AG Medical Solutions | 2008-04-22 | Traditional | PDF ↗ |
| K080351 | DEXELA DEX TOP MAMMOGRAPHY WORKSTATION, MODEL MAMWKVI | Dexela, Ltd. | 2008-04-22 | Traditional | PDF ↗ |
| K080961 | NM APPLICATION SUITE | Philips Nuclear Medicine, Inc. | 2008-04-18 | Traditional | PDF ↗ |
| K080608 | DIGITAL LIGHTBOX | Brainlab AG | 2008-04-17 | Traditional | PDF ↗ |
| K073449 | SURGICASE | Materialise NV | 2008-04-16 | Traditional | PDF ↗ |
| K080770 | IMAGENMD WITH IMAGENQ | Cardiovascular Imaging Technologies, LLC | 2008-04-09 | Traditional | PDF ↗ |
| K080325 | IGROK | Igrok, LLC | 2008-04-08 | Traditional | PDF ↗ |
| K073468 | MIMICS | Materialise NV | 2008-04-02 | Traditional | PDF ↗ |
| K080457 | COLOR LCD MONITOR, MODEL RADIFORCE RX211 | Eizo Nanao Corporation | 2008-03-20 | Special | PDF ↗ |
| K073176 | KANTERON DICOM STATION (KDS), MODEL 3.0 | Monica Veytia | 2008-03-19 | Traditional | PDF ↗ |
| K073714 | TRAUMACAD VERSION 2.0 | Orthocrat, Ltd. | 2008-03-19 | Traditional | PDF ↗ |
| K073526 | AMICAS VISION SERIES PACS, MODEL 5.5 | Amicas, Inc. | 2008-03-12 | Traditional | PDF ↗ |
| K073062 | OMNI-VUE SYSTEM | Genesis Digital Imaging, Inc. | 2008-03-10 | Traditional | PDF ↗ |
| K080422 | 5 MEGAPIXEL MONOCHROME LCD MONITOR, MODEL RADIFORCE GS520 | Eizo Nanao Corporation | 2008-03-10 | Special | PDF ↗ |
| K073418 | SYNGO IMAGING CCF VA10A | Siemens AG Medical Solutions | 2008-02-29 | Traditional | PDF ↗ |
| K080290 | XVIEWNET | American Radiologist Network, Inc. | 2008-02-22 | Traditional | PDF ↗ |
| K080333 | IMAGEGRID | Candelis, Inc. | 2008-02-22 | Traditional | PDF ↗ |
| K073704 | I-DIXEL | J. Morita USA, Inc. | 2008-02-21 | Traditional | PDF ↗ |
| K080320 | PRIMEVUE 21 3MP COLOR DISPLAY, MODEL AC-QX21-A9300 | Nds Surgical Imaging | 2008-02-21 | Traditional | PDF ↗ |
| K080334 | INSTARAD | Medsphere Technologies Pvt , Ltd. | 2008-02-21 | Traditional | PDF ↗ |
| K072821 | VITREA 4DCT | Vital Images, Inc. | 2008-02-20 | Traditional | PDF ↗ |
| K073007 | CORONIS FUSION 6MP DL, MODEL: MDCC 6130 DL | Barcoview, Medical Imaging Systems | 2008-02-14 | Traditional | PDF ↗ |
| K073194 | CMRTOOLS AND PLUG-INS VENTRICULAR TOOLS & THALASSAEMIA TOOLS | Cardiovascular Imaging Solutions , Ltd. | 2008-02-14 | Traditional | PDF ↗ |
| K071794 | 15M MONOCHROME DIGITAL MAMMOGRAPHY LCD MONITOR MDL2123A (MS51I2) | Totoku Electric Co., Ltd. | 2008-02-11 | Traditional | PDF ↗ |
| K072653 | 3VISEON/SURGERY | 3Mensio Medical Imaging BV | 2008-01-24 | Traditional | PDF ↗ |
| K072875 | NIO 5MP DISPLAY, MODEL E5620 | Barcoview, Medical Imaging Systems | 2008-01-22 | Traditional | PDF ↗ |
| K073292 | MM/MMA/COLOR SERIES DIGITAL FLAT PANEL DISPLAY SYSTEM | Heeyoung Co., Ltd. | 2008-01-18 | Traditional | PDF ↗ |
| K080013 | REGISTRATION AND FUSION | Agfa Healthcare Corporation | 2008-01-17 | Traditional | PDF ↗ |
| K073169 | SCIMAGE PICOMENTERPRISE | Scimage, Inc. | 2008-01-09 | Traditional | PDF ↗ |
| K073306 | XORANCONNECT | Xoran Technologies, Inc. | 2008-01-07 | Traditional | PDF ↗ |
| K073259 | XIDF-100A/B1 IMAGE PROCESSOR | Toshiba America Medical Systems, In.C | 2007-12-20 | Traditional | PDF ↗ |
| K073448 | MEDICAL DISPLAY, MD205MG | Nec Display Solutions , Ltd. | 2007-12-20 | Traditional | PDF ↗ |
| K073340 | COLOR LCD MONITOR, FLEXSCAN MX300W | Eizo Nanao Corporation | 2007-12-19 | Special | PDF ↗ |
| K073205 | NIO 5MP, MODEL MDNG-5121 | Barcoview, Medical Imaging Systems | 2007-12-19 | Special | PDF ↗ |
| K073272 | WORKSTATIONONE BREAST IMAGING WORKSTATION | Three Palm Software, LLC | 2007-12-11 | Traditional | PDF ↗ |
| K072637 | DIVO | A2d Imaging, LLC | 2007-12-11 | Traditional | PDF ↗ |
| K073271 | ORTHOGON | Agfa Healthcare Corporation | 2007-12-05 | Traditional | PDF ↗ |
| K072986 | INTEGRADWEB PACS SYSTEM | GE Healthcare | 2007-11-20 | Special | PDF ↗ |
| K072952 | GE ECHOPAC | General Electric Co. | 2007-11-16 | Special | PDF ↗ |
| K072960 | CDP 5000, MEDIA AND DISTRIBUTION CENTER, DIAGNET | Cdp, Ltd. | 2007-11-08 | Traditional | PDF ↗ |
| K072972 | MEDSTREAMING MEDICAL OFFICE SOFTWARE | Medstreaming, LLC | 2007-11-06 | Traditional | PDF ↗ |
| K072532 | TRUEPIX LCD MEDICAL DISPLAY MONITOR, MODELS TX-5M, TX-3M, TX-2M | Dooyang Systems, Inc. | 2007-11-02 | Traditional | PDF ↗ |
| K072665 | SUNIRAY 5.2 | Orangedental GmbH & Co. KG | 2007-10-03 | Traditional | PDF ↗ |
| K071964 | MIM 4.1 (SEASTAR) | Mimvista Corp. | 2007-09-26 | Traditional | PDF ↗ |
| K072242 | COR ANALYZER II, MODEL V1.7 | Rcadia Medical Imaging , Ltd. | 2007-09-11 | Special | PDF ↗ |
| K071584 | OASIS RELEASE 1.0 | Segami Corporation | 2007-08-31 | Traditional | PDF ↗ |
| K072205 | VISAGE PACS/CS, RELEASE VERSION 5.0 | Mercury Computer Systems, Inc. | 2007-08-29 | Special | PDF ↗ |
| K071492 | FIRSTVIEW | Riverain Medical Group,Llc | 2007-08-28 | Traditional | PDF ↗ |
| K071894 | XEBRA DICOM IMAGE BROWSER | Hx Technologies, Inc. | 2007-08-16 | Traditional | PDF ↗ |
| K072065 | 20.8-INCH (53CM) COLOR LCD MONITOR CDL2119A (CCL352I2) | Totoku Electric Co., Ltd. | 2007-08-14 | Traditional | PDF ↗ |
| K072066 | 1.3M MONOCHROME LCD MONITOR MDL1908A | Totoku Electric Co., Ltd. | 2007-08-14 | Traditional | PDF ↗ |
| K071636 | CODIAGNOSTIX (R) 5.72 | Ivs Solutions AG | 2007-08-09 | Abbreviated | PDF ↗ |
| K063066 | AXIS-V MONOCHROME 5 MP DISPLAY | National Display Systems | 2007-08-03 | Traditional | PDF ↗ |
| K071972 | ORTHOPEDIC SOFTWARE FOR IMPAX WORKSTATIONS | Agfa Healthcare Corp. | 2007-07-30 | Traditional | PDF ↗ |
| K071950 | SYNGO TRUED | Siemens Medical Solutions USA, Inc. | 2007-07-27 | Traditional | PDF ↗ |
| K071602 | IMAGIC V2.0 | Ashva Technologies, Pvt., Ltd. | 2007-07-23 | Traditional | PDF ↗ |
| K071166 | UNIWEB, VERSION 5.0 | Electronic Business Machine Co., Ltd. (Ebm) | 2007-07-23 | Abbreviated | PDF ↗ |
| K071599 | EASYGUIDE | Keystone Dental, Inc. | 2007-07-11 | Special | PDF ↗ |
| K071436 | REGIUS UNITEA | Konica Minolta Medical & Graphic, Inc. | 2007-06-27 | Traditional | PDF ↗ |
| K062878 | EZPACS, VERSION 3.0 | Advanced Imaging Solutions, LLC | 2007-06-27 | Abbreviated | PDF ↗ |
| K071297 | IMPAX SE SIGMACOM CLIENT (PACS WORKSTATION) | Agfa Healthcare Corp. | 2007-06-22 | Traditional | PDF ↗ |
| K071232 | IMAGE-ARENA APPLICATIONS AND RESEARCH-ARENA APPLICATIONS | Tomtec Imaging Systems GmbH | 2007-06-20 | Special | PDF ↗ |
| K071241 | LMS-LIVER | Median Technologies | 2007-06-08 | Traditional | PDF ↗ |
| K071086 | RESOLUTIONMD CARDIAC PRODUCT FAMILY, MODEL: RELEASE 1.0 | Calgary Scientific, Inc. | 2007-06-01 | Traditional | PDF ↗ |
| K071362 | VITAL CONNECT 4.1 | Vital Images, Inc. | 2007-05-30 | Abbreviated | PDF ↗ |
| K071331 | VITREA VERSION 4.0 | Vital Images, Inc. | 2007-05-25 | Abbreviated | PDF ↗ |
| K063269 | 5MP MEDICAL MONOCHROME REFERENCE DISPLAY, MODEL MDM2010-5NC | Chi Lin Technology Co., Ltd. | 2007-05-23 | Traditional | PDF ↗ |
| K071054 | RADIODEXTER, DEXTROSCOPE, DEXTROBEAM, MODELS 1.0, MK10, MK3 & MK4 | Volume Interactions Pte, Ltd. | 2007-05-22 | Traditional | PDF ↗ |
| K070831 | VOXAR 3D ENTERPRISE WITH COLONMETRIX AND PET/CT PERFUSION | Barcoview Mis Edinburgh | 2007-05-22 | Traditional | PDF ↗ |
| K071114 | SYNGO IMAGING (VERSION V30) | Siemens AG Medical Solutions | 2007-05-22 | Traditional | PDF ↗ |
| K070868 | LMS-LUNG/TRACK | Median Technologies | 2007-05-15 | Traditional | PDF ↗ |
| K071000 | MYRIAN | Intrasense | 2007-05-14 | Traditional | PDF ↗ |
| K070755 | INTERWORKS | Avreo, Inc. | 2007-05-08 | Traditional | PDF ↗ |
Product code LLZ · Class II · Radiology. Data: openFDA.