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 17 of 23
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K061472 | GALILEOS IMPLANT, V 1.0 | Sicat GmbH & Co. KG | 2006-06-09 | Traditional | PDF ↗ |
| K061061 | 20.1-INCH (51CM) COLOR LCD MONITOR CDL2009A (CCL204) | Tokotu Electric Co., Ltd. | 2006-06-07 | Traditional | PDF ↗ |
| K061035 | TIGERVIEW PROFESSIONAL | Televere Systems | 2006-06-05 | Traditional | PDF ↗ |
| K061372 | CENTRICITY AW SUITE OPTION | Ge Healthcare Information Technologies | 2006-05-30 | Traditional | PDF ↗ |
| K061396 | QLAB QUANTIFICATION SOFTWARE | Philips Ultrasound, Inc. | 2006-05-30 | Traditional | PDF ↗ |
| K061326 | VOXAR 3D ENTERPRISE WITH CARDIAMETRIX | Barcoview Mis Edinburgh | 2006-05-25 | Traditional | PDF ↗ |
| K061303 | MEDICAL DISPLAY, MODELS MDM 1900-1NG AND MDM 1900-1NR | Chi Lin Technology Co., Ltd. | 2006-05-25 | Traditional | PDF ↗ |
| K061305 | MEDICAL DISPLAY, MDC1900-1LG (1LR) | Chi Lin Technology Co., Ltd. | 2006-05-25 | Traditional | PDF ↗ |
| K060950 | 3MATIC | Materialise NV | 2006-05-18 | Traditional | PDF ↗ |
| K060816 | MIM 4.0 (NEURO | Mimvista Corp. | 2006-05-16 | Traditional | PDF ↗ |
| K061214 | AQUARIUSAPS SERVER | Terarecon,Inc. | 2006-05-15 | Traditional | PDF ↗ |
| K061126 | ACCUREX | Cybermed, Inc. | 2006-05-09 | Traditional | PDF ↗ |
| K060961 | 15-INCH (38CM) COLOR LCD MONITOR CDL1566A | Totoku Electric Co., Ltd. | 2006-05-01 | Traditional | PDF ↗ |
| K061029 | JETSTREAM WORKSPACE | Adac Laboratories | 2006-05-01 | Traditional | PDF ↗ |
| K060992 | SYNGO US WORKPLACE | Siemens Medical Solutions | 2006-04-28 | Traditional | PDF ↗ |
| K061018 | PLANAR DOME EX LINE MODEL DOME E2C | Planar Systems, Inc. | 2006-04-28 | Traditional | PDF ↗ |
| K060845 | MONOCHROME LCD MONITOR, RADIFORCE MODEL GS310 | Eizo Nanao Corporation | 2006-04-25 | Special | PDF ↗ |
| K060941 | CAAS MRV VERSION 3.0 | Pie Medical Imaging BV | 2006-04-19 | Special | PDF ↗ |
| K060840 | SVIEW | Mri Cardiac Services, Incorporated | 2006-04-07 | Traditional | PDF ↗ |
| K052424 | MAXILIM | Medicim NV | 2006-03-31 | Traditional | PDF ↗ |
| K060505 | VOXAR 3D ENTERPRISE, MODEL 6.1 | Barcoview Mis Edinburgh | 2006-03-29 | Special | PDF ↗ |
| K060451 | M-VU VIEWER STATION | Vucomp, Inc. | 2006-03-22 | Traditional | PDF ↗ |
| K060267 | VIRTUAL IMPLANT PLACEMENT (VIP) DENTAL IMPLANT SURGERY PLANNING SOFTWARE | Implant Logic Systems, Ltd. | 2006-03-17 | Traditional | PDF ↗ |
| K060263 | IQPACS | S.C. Info World S.R.L. | 2006-03-15 | Traditional | PDF ↗ |
| K060453 | AZE VIRTUALPLACE | Aze, Ltd. | 2006-03-09 | Traditional | PDF ↗ |
| K060378 | VITREA2 VERSION 3.8.1 | Vital Images, Inc. | 2006-03-09 | Abbreviated | PDF ↗ |
| K060035 | MDXNET | Cybermdx, Inc. | 2006-03-09 | Abbreviated | PDF ↗ |
| K053039 | CLINTON ELECTRONICS SERIES II DIGITAL GRAYSCALE MONITORS, MODELS DL2000, DL3000, DL2000 OF AND DL3000 OF | Clinton Electronics Corp. | 2006-03-01 | Traditional | PDF ↗ |
| K053183 | JIVE X SOFTWARE | Visus Technology Transfer GmbH | 2006-02-16 | Traditional | PDF ↗ |
| K060210 | MEDIPORT | Maxant Technologies, Inc. | 2006-02-10 | Traditional | PDF ↗ |
| K053592 | SIMPLANT DR. JAMES | Materialise NV | 2006-02-08 | Special | PDF ↗ |
| K060055 | KODAK PACS | Eastman Kodak Company | 2006-02-07 | Traditional | PDF ↗ |
| K053301 | CEDARA I-RESPONSE CEDARA PET/CT | Cedara Software Corp. | 2006-02-03 | Traditional | PDF ↗ |
| K060136 | PLANAR DOME EX SERIES DIGITAL FLAT-PANEL DISPLAY SYSTEM, MODEL E4C COLOR | Planar Systems, Inc. | 2006-01-31 | Traditional | PDF ↗ |
| K053455 | ENCOMPASS.NET | Empiric Systems, LLC | 2006-01-25 | Traditional | PDF ↗ |
| K053347 | KODAK CARESTREAM PACS | Eastman Kodak Company | 2006-01-04 | Special | PDF ↗ |
| K052988 | CAAS | Pie Medical Imaging BV | 2005-12-30 | Traditional | PDF ↗ |
| K052942 | 21.3INCH MONOCHROME LCD MONITOR | Nec-Mitsubishi Electric Visual Systems Corp. | 2005-12-27 | Traditional | PDF ↗ |
| K053458 | WEB1000 | Agfa Corp. | 2005-12-22 | Traditional | PDF ↗ |
| K052467 | BRAIN VIEWRX VIEWER, VERSION 1.0 | Kyron Clinical Imaging, Inc. | 2005-12-20 | Traditional | PDF ↗ |
| K052120 | LUMIMED MONOCHROME LCD MONITOR, MODELS MM 20, MM 30 AND MM50 | Heeyoung Co., Ltd. | 2005-12-16 | Traditional | PDF ↗ |
| K052632 | VITREA2 VERSION 3.8 MEDICAL IMAGE PROCESSING SOFTWARE | Vital Images, Inc. | 2005-12-15 | Traditional | PDF ↗ |
| K053162 | DEXTROSCOPE & DEXTROBEAM | Volume Interactions Pte, Ltd. | 2005-12-09 | Special | PDF ↗ |
| K053281 | EVMS (ENTERPRISE VISUAL MEDICAL SYSTEM SOFTWARE) | Emageon, Inc. | 2005-12-07 | Traditional | PDF ↗ |
| K053133 | SYNGO DYNAMICS, VERSION 5.0 | Siemens Medical Solutions USA, Inc. | 2005-12-05 | Traditional | PDF ↗ |
| K052963 | MEDIQ VERSION 1.0 | Clario Medical Imaging, Inc. | 2005-12-05 | Traditional | PDF ↗ |
| K053155 | VIMPLANT | Cybermed, Inc. | 2005-11-23 | Traditional | PDF ↗ |
| K053010 | VISTADENT AT COMPLETE, MODEL 3.1 | Dentsply Intl., Inc. | 2005-11-22 | Traditional | PDF ↗ |
| K053043 | ENCOMPASS SOFTWARE PACKAGE | Toshiba America Medical Systems, In.C | 2005-11-18 | Traditional | PDF ↗ |
| K052618 | IMAGECAST PACS | Idx Systems Corp. | 2005-11-17 | Traditional | PDF ↗ |
| K052537 | CATELLA DIAGNOSTIC WORKSTATION, VERSION 4.0 | American Medical Sales, Inc. | 2005-11-16 | Abbreviated | PDF ↗ |
| K052958 | COLOR NIO 2MP, E-2320 C | Barcoview | 2005-11-16 | Traditional | PDF ↗ |
| K052995 | ADVANTAGE WORKSTATION 4.3. | GE Healthcare | 2005-11-08 | Traditional | PDF ↗ |
| K052545 | INFINITT G3 PACS | Infinitt Co., Ltd. | 2005-11-08 | Traditional | PDF ↗ |
| K052379 | MIM 3.5 (CIRCA) | Mimvista Corp. | 2005-10-31 | Traditional | PDF ↗ |
| K052775 | SYNGO MULTIMODALITY WORKPLACE (SYNGO MM WP) | Siemens AG Medical Solutions | 2005-10-31 | Traditional | PDF ↗ |
| K052895 | FOURSIGHT VIEWTOOL IMAGE VIEWER | Siemens Medical Solutions USA, Inc. | 2005-10-27 | Traditional | PDF ↗ |
| K052284 | REFORMAT GATEWAY | Infinitt Co., Ltd. | 2005-10-17 | Traditional | PDF ↗ |
| K052312 | WIDE 5MP (MAMMO) LCD MONITOR SYSTEM | Wide Corporation | 2005-10-07 | Traditional | PDF ↗ |
| K052358 | ETIAM STAR PACS COMPONENTS | Etiam, S.A. | 2005-10-05 | Traditional | PDF ↗ |
| K052529 | E-2320 PA S | Barcoview | 2005-09-30 | Traditional | PDF ↗ |
| K052352 | COLOR CORONIS 2MP-21 AND MFCD 2321 | Barcoview | 2005-09-30 | Traditional | PDF ↗ |
| K052478 | MFCD 1219, MFCD 1219 TS | Barcoview | 2005-09-28 | Traditional | PDF ↗ |
| K052199 | 21.3-INCH(54 CM) MONOCHROME LCD MONITOR MDL2115A (ME353I), (DV3MM-HB), (ME353IM) | Totoku Electric Co., Ltd. | 2005-09-22 | Traditional | PDF ↗ |
| K052461 | SYNGO IMAGING VERSION V20A | Siemens AG Medical Solutions | 2005-09-22 | Traditional | PDF ↗ |
| K052460 | POWERSERVER, POWERREADER, GATEWAY AND POWERCACHE | Ramsoft, Inc. | 2005-09-21 | Traditional | PDF ↗ |
| K052276 | NIO 2MP-20 AND E-2620 S | Barcoview | 2005-09-21 | Traditional | PDF ↗ |
| K052411 | HIPAX MEDICAL IMAGING SOFTWARE | Steinhart Medizinsysteme GmbH | 2005-09-21 | Traditional | PDF ↗ |
| K052403 | CORONIS 2MP-21 AND MFGD 2621 | Barcoview | 2005-09-15 | Traditional | PDF ↗ |
| K052429 | CORONIS 3MP-21 AND MFGD 3621 | Barcoview | 2005-09-15 | Traditional | PDF ↗ |
| K052344 | COLOR LCD MONITOR, MODEL RADIOFORCE R31 & R31-C | Eizo Nanao Corporation | 2005-09-14 | Special | PDF ↗ |
| K052337 | MONOCHROME LCD MONITOR, MODEL RADIFORCE G33 | Eizo Nanao Corporation | 2005-09-08 | Special | PDF ↗ |
| K052159 | AIDA COMPACT II SYSTEM | KARL STORZ Endoscopy-America, Inc. | 2005-09-07 | Special | PDF ↗ |
| K051853 | CARDIOSTREAM SONOAIM | Cardiostream, LLC | 2005-08-22 | Traditional | PDF ↗ |
| K051901 | NIO 3MP-21 | Barcoview | 2005-08-17 | Traditional | PDF ↗ |
| K051813 | ULTRAPACS | Ultrarad Corporation | 2005-08-15 | Traditional | PDF ↗ |
| K051840 | ENSITE VERISMO SOFTWARE | St Jude Medical | 2005-08-15 | Traditional | PDF ↗ |
| K051809 | EASYVIZ, EASYVIZ SYSTEM, EASYVIZ PACS SYSTEM, EASYVIZ IMAGE AND DATA MANAGEMENT SYSTEM | Medical Insight A/S | 2005-08-15 | Traditional | PDF ↗ |
| K051902 | NIO 2MP-21 | Barcoview | 2005-08-11 | Traditional | PDF ↗ |
| K051586 | VIEWSEND MEDICAL SYSTEM | Kenei Co., Ltd. | 2005-08-04 | Traditional | PDF ↗ |
| K051715 | STARPACS DENTAL | Infinitt Co., Ltd. | 2005-08-02 | Traditional | PDF ↗ |
| K051649 | VERICIS CARDIOVASCULAR IMAGE AND INFORMATION SYSTEM, MODEL 4.0 | Camtronics Medical Systems | 2005-08-02 | Traditional | PDF ↗ |
| K051639 | AS-OBGYN INFORMATION SYSTEM; AS-EMR SYSTEM | As Software, Inc. | 2005-08-02 | Abbreviated | PDF ↗ |
| K050862 | 3TP WORKSPACE | 3tp, LLC | 2005-07-25 | Traditional | PDF ↗ |
| K051743 | R2 BREAST IMAGING WORKSTATION | R2 Technology, Inc. | 2005-07-25 | Traditional | PDF ↗ |
| K051528 | MEVIS LIVERANALYSER/LIVERVIEWER SOFTWARE | Mevis Technology GmbH & Co. KG | 2005-07-20 | Traditional | PDF ↗ |
| K051523 | REGIUS CONSOLE CS-2000 AND REGIUS CONSOLE CS-3000, MEDICAL IMAGE PROCESSING WORKSTATION | Konica Minolta Medical & Graphic, Inc. | 2005-07-20 | Traditional | PDF ↗ |
| K051673 | XELERIS 2 PROCESSING AND REVIEW WORKSTATION | GE Medical Systems | 2005-07-18 | Special | PDF ↗ |
| K051403 | 19-INCH (48CM) COLOR LCD MONITOR CDL1904A | Totoku Electric Co., Ltd. | 2005-07-14 | Traditional | PDF ↗ |
| K051745 | ECHOSYSTEM | Medstrat, Inc. | 2005-07-14 | Abbreviated | PDF ↗ |
| K051553 | FUJI SYNAPSE WORKSTATION SOFTWARE | Fujifilm Medical Systems U.S.A, Inc. | 2005-07-07 | Traditional | PDF ↗ |
| K051392 | BTI-SCAN, VERSION 4.0 | B.T.I. Biotechnology Institute, Sl. | 2005-06-29 | Traditional | PDF ↗ |
| K051521 | REGIUS RS-1000, MEDICAL IMAGE PROCESSING WORKSTATION | Konica Minolta Medical & Graphic, Inc. | 2005-06-28 | Traditional | PDF ↗ |
| K051037 | IMAGEQUBE PACS | Intuitive Imaging Informatics, LLC | 2005-06-28 | Traditional | PDF ↗ |
| K051331 | 19-INCH (48 CM) COLOR LCD MONITOR CDL1902A | Totoku Electric Co., Ltd. | 2005-06-27 | Traditional | PDF ↗ |
| K051315 | MODIFICATION TO: SECTRA IDS5 WORKSTATION | Sectra Imtec AB | 2005-06-15 | Special | PDF ↗ |
| K051325 | WEBPAX, MODEL 200 | Heart Imaging Technologies, LLC | 2005-06-15 | Traditional | PDF ↗ |
| K051127 | KIKA IMAGING LAB VIEWER, MODEL 2.0.1.0 | Kika Medical, Inc. | 2005-06-03 | Traditional | PDF ↗ |
| K050993 | MMS VIDEO OPTION | Medical Measurement Systems B.V. | 2005-05-26 | Traditional | PDF ↗ |
| K050846 | B-CAD SYSTEM, VERSION 1.0 | The Medipattern Corporation | 2005-05-26 | Traditional | PDF ↗ |
Product code LLZ · Class II · Radiology. Data: openFDA.