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 18 of 23
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K051201 | E1 MEDICAL FLAT PANEL DISPLAY SYSTEM AND MFGD 1218 MEDICAL FLAT PANEL DISPLAY | Barcoview | 2005-05-26 | Traditional | PDF ↗ |
| K050943 | GE VIEWPOINT | General Electric Co. | 2005-05-23 | Traditional | PDF ↗ |
| K051081 | ESSENPACS | Cymed Engineering, Inc. | 2005-05-12 | Traditional | PDF ↗ |
| K050736 | IMORGON ULTRASOUND PACS SOLUTIONS | Sea Ridge Software, Inc. | 2005-05-05 | Traditional | PDF ↗ |
| K050619 | 20.8-INCH (53CM) COLOR LCD MONITOR, MODELS CDL2112A, CCL350I & DV3MC-HB | Totoku Electric Co., Ltd. | 2005-04-26 | Traditional | PDF ↗ |
| K050617 | 21.3-INCH (54CM) MONOCHROME LCD MONITOR, MODELS MDL2109A, ME251I & DV2MM-HB | Totoku Electric Co., Ltd. | 2005-04-22 | Traditional | PDF ↗ |
| K050703 | QBRAIN | Medis Medical Imaging Systems BV | 2005-04-21 | Traditional | PDF ↗ |
| K050751 | IMPAX ORTHOPAEDIC WORKSTATION, MODEL IMPAX ES 5.X | Agfa Corp. | 2005-04-21 | Special | PDF ↗ |
| K050616 | 21.3-INCH (54CM) COLOR LCD MONITOR, MODELS CDL2113A, CCL250I & DV2MC-HB | Totoku Electric Co., Ltd. | 2005-04-21 | Traditional | PDF ↗ |
| K050744 | KAVO ERGOCOM/ERGOCAM | Kavo America Corporation | 2005-04-21 | Traditional | PDF ↗ |
| K050485 | 20.8-INCH(53CM) MONOCHROME LCD MONITOR MDL2110A (ME351I), (DV3MM-HB) | Totoku Electric Co., Ltd. | 2005-04-07 | Traditional | PDF ↗ |
| K050376 | PROWIN | Medical Technologies International, Inc. | 2005-04-07 | Traditional | PDF ↗ |
| K050341 | IMPLANT LOCATION SOFTWARE, MODEL 0.1.0 | Tactile Technologies, Ltd. | 2005-03-29 | Traditional | PDF ↗ |
| K050667 | R2 FAMILY OF IMAGE DISPLAY UNITS WITH R2 UNIFORM DISPLAY SOFTWARE | R2 Technology, Inc. | 2005-03-29 | Traditional | PDF ↗ |
| K050298 | IPACS PRISM-5.0 | Realtimeimage, Inc. | 2005-02-28 | Traditional | PDF ↗ |
| K050196 | SECTRA IDS5 WORKSTATION | Sectra Imtec AB | 2005-02-24 | Special | PDF ↗ |
| K050228 | AGFA HEARTLAB CARDIOVASCULAR | Heartlab, Inc. | 2005-02-18 | Special | PDF ↗ |
| K050033 | LUCION | Mevisys Co., Ltd. | 2005-02-11 | Traditional | PDF ↗ |
| K042755 | MONOCHROME LCD MONITOR, RADIFORCE G51 | Eizo Nanao Corporation | 2005-02-10 | Traditional | PDF ↗ |
| K043122 | SMD 21500 OR DSB-2103-D-5MP-5M PIXEL GRAYSCALE FLAT PANEL DISPLAY | Siemens AG | 2005-02-09 | Traditional | PDF ↗ |
| K043430 | 20.8-INCH (53 CM) COLOR LCD MONITOR, MODELS CDL2114A AND DV3MC-HB | Totoku Electric Co., Ltd. | 2005-01-28 | Traditional | PDF ↗ |
| K043483 | RADIN, MODEL V 3.0 | Sohard AG | 2005-01-28 | Traditional | PDF ↗ |
| K043415 | CENTRICITY PACS SYSTEM | Ge Medical Systems Information Technologies | 2005-01-21 | Traditional | PDF ↗ |
| K043194 | VOXAR 3D PRODUCT FAMILY | Voxar Limited | 2005-01-11 | Traditional | PDF ↗ |
| K043216 | CADSTREAM VERSION 4.0 | Confirma, Inc. | 2005-01-06 | Traditional | PDF ↗ |
| K042868 | MAMMOREPORT SOFTCOPY WORKSTATION | Siemens Medical Solutions USA, Inc. | 2005-01-06 | Special | PDF ↗ |
| K043360 | IMT.LAB | Pie Medical | 2005-01-05 | Traditional | PDF ↗ |
| K043146 | HORIZON MEDICAL IMAGING | Mckesson Medical Imaging Company | 2005-01-04 | Traditional | PDF ↗ |
| K042221 | CORONIS 5MP MEDICAL FLAT PANEL DISPLAY SYSTEM | Barco NV Barcoview | 2004-12-30 | Traditional | PDF ↗ |
| K041078 | SURGPLAN AND PANPLAN | Imaging Sciences Intl., Inc. | 2004-12-23 | Traditional | PDF ↗ |
| K043412 | MODIFICATION TO: VIEWSTATION | Impac Medical Systems, Inc. | 2004-12-20 | Special | PDF ↗ |
| K043333 | VITREA2, VERSION 3.7 MEDICAL IMAGE PROCESSING SYSTEM | Vital Images, Inc. | 2004-12-15 | Abbreviated | PDF ↗ |
| K043350 | MISTAR, MODEL V3.2 | Apollo Medical Imaging Technology Pty. , Ltd. | 2004-12-15 | Traditional | PDF ↗ |
| K043134 | METRX WORKSTATION | Medical Metrx Solutions, Inc. | 2004-12-13 | Traditional | PDF ↗ |
| K042353 | AXIS I (1MP), II (2MP), III (3MP), AND V (5MP) MONOCHROME DISPLAYS | National Display Systems | 2004-11-24 | Traditional | PDF ↗ |
| K042995 | X-LEONARDO | Siemens Medical Solutions USA, Inc. | 2004-11-24 | Special | PDF ↗ |
| K042662 | NIO 5MP MEDICAL FLAT PANEL DISPLAY SYSTEM | Barco NV Barcoview | 2004-11-22 | Traditional | PDF ↗ |
| K042942 | MGP 15 DICOM THEATER | Barco NV Barcoview | 2004-11-22 | Traditional | PDF ↗ |
| K042660 | NIO 2MP MEDICAL FLAT PANEL DISPLAY SYSTEM | Barco NV Barcoview | 2004-11-19 | Traditional | PDF ↗ |
| K042697 | SECOND LOOK VIEWER | Icad, Inc. | 2004-11-19 | Traditional | PDF ↗ |
| K042661 | NIO 3MP MEDICAL FLAT PANEL DISPLAY SYSTEM | Barco NV Barcoview | 2004-11-19 | Traditional | PDF ↗ |
| K043097 | 3VISEON | 3Mensio Medical Imaging BV | 2004-11-19 | Traditional | PDF ↗ |
| K042816 | TRAUMACAD 1.2 | Orthocrat, Ltd. | 2004-11-10 | Traditional | PDF ↗ |
| K042700 | IMAGE MEDICAL ACQUISITION STATION (IMAS) | Erad Imagemedical Corp. | 2004-11-08 | Traditional | PDF ↗ |
| K042867 | PHILIPS ORTHOPAEDIC APPLICATIONS | Philips Medical Systems North America, Inc. | 2004-11-02 | Traditional | PDF ↗ |
| K042832 | SIENET COSMOS (VERSION V15A) | Siemens AG Medical Solutions | 2004-10-28 | Traditional | PDF ↗ |
| K042212 | IMPLANTMASTER | I-Dent | 2004-10-21 | Traditional | PDF ↗ |
| K042383 | RSA-CMS | Medis Medical Imaging Systems BV | 2004-10-20 | Traditional | PDF ↗ |
| K042781 | IPACS CARDIO | Realtimeimage, Inc. | 2004-10-19 | Traditional | PDF ↗ |
| K042634 | WIDE 1MP LCD MONITOR SYSTEM | Wide Corporation | 2004-10-08 | Traditional | PDF ↗ |
| K042647 | EXAM-PACS | Coactiv, LLC | 2004-10-07 | Traditional | PDF ↗ |
| K042692 | CLARITY FUSION | Shared P.E.T. Imaging, LLC | 2004-10-07 | Special | PDF ↗ |
| K042525 | CENTRICITY RADIOLOGY RA600/CENTRICITY CARDIOLOGY CA1000/CENTRICITY DIGITAL HARDCOPY WORKSTATION | Ge Medical Systems Information Technologies | 2004-10-01 | Traditional | PDF ↗ |
| K042507 | UBIPACS | Icm Co., Ltd. | 2004-09-27 | Traditional | PDF ↗ |
| K042334 | ALLURA 3D-CA, RELEASE 1 | Philips Medical Systems North America Co. | 2004-09-27 | Traditional | PDF ↗ |
| K042203 | LEONARDO SYNGO CARDIOLOGY WORKSTATION | Siemens Medical Solutions USA, Inc. | 2004-09-24 | Traditional | PDF ↗ |
| K042042 | ULTRASOUND CAPTURE SYSTEM | Heartlab, Inc. | 2004-09-21 | Abbreviated | PDF ↗ |
| K042311 | PACSPARTNER | Medical Standard Co., Ltd. | 2004-09-09 | Traditional | PDF ↗ |
| K042313 | INTEGRADWEB MPR/MIP | Dynamic Imaging, Inc. | 2004-09-09 | Traditional | PDF ↗ |
| K042292 | ISITE PACS | Stentor, Inc. | 2004-09-08 | Traditional | PDF ↗ |
| K042008 | ULTRAVISUAL | Emageon Uv, Inc. | 2004-09-03 | Traditional | PDF ↗ |
| K041508 | BARCOVIEW CORONIS 5MP HD MEDICAL FLAT PANEL DISPLAY SYSTEM | Barco NV Barcoview | 2004-08-27 | Traditional | PDF ↗ |
| K041782 | SEEMOR 5.0 IMAGE DISPLAY PROGRAM | Areeda Assoc., Ltd. | 2004-08-16 | Traditional | PDF ↗ |
| K041935 | DR SYSTEMS PACS, RELEASE 6.1 | Dr Systems, Inc. | 2004-08-16 | Traditional | PDF ↗ |
| K041555 | SECURVIEW DX SOFTCOPY WORKSTATION | Hologic, Inc. | 2004-08-09 | Traditional | PDF ↗ |
| K041990 | FUJI MEDICAL CR CONSOLE, MODEL FLASH IIP | Fujifilm Medical System U.S.A., Inc. | 2004-08-06 | Traditional | PDF ↗ |
| K041484 | UNDECIDED | Siemens Medical Solutions USA, Inc. | 2004-07-30 | Traditional | PDF ↗ |
| K040686 | M'ATH STD | Intelligence IN Medical Technologies | 2004-07-30 | Traditional | PDF ↗ |
| K041326 | MEDCOMMONS OPEN RADIOLOGY GATEWAY | Medcommons, Inc. | 2004-07-27 | Abbreviated | PDF ↗ |
| K041162 | ORTHO-CMS | Medis Medical Imaging Systems BV | 2004-07-27 | Traditional | PDF ↗ |
| K041682 | CAAS MRV | Pie Medical Imaging BV | 2004-07-27 | Traditional | PDF ↗ |
| K040931 | PATXFER RT | Brainlab AG | 2004-07-22 | Traditional | PDF ↗ |
| K040896 | MODIFICATION TO ENCOMPASS | Heartlab, Inc. | 2004-07-16 | Traditional | PDF ↗ |
| K041761 | RAPIDIACOLON | Infinitt Co., Ltd. | 2004-07-13 | Traditional | PDF ↗ |
| K041737 | 5M MONOCHROME DIGITAL MAMMOGRAPHY LCD MONITOR ME511L (MDL2105A) | Totoku Electric Co., Ltd. | 2004-07-13 | Special | PDF ↗ |
| K041029 | KINETDX | Siemens Medi Cal Solutions, Inc. | 2004-07-08 | Traditional | PDF ↗ |
| K040970 | LEONARDO | Siemens Medical Systems, Inc. | 2004-07-08 | Traditional | PDF ↗ |
| K041597 | MONOCHROME LCD MONITOR, MODEL RADIFORCE G22 | Eizo Nanao Corporation | 2004-06-24 | Special | PDF ↗ |
| K041581 | COMPACS, VERSION 1.0 | Intelligent Images Srl | 2004-06-22 | Traditional | PDF ↗ |
| K041500 | STARPACS ORTHOPEDICS SYSTEM | Infinitt Co., Ltd. | 2004-06-21 | Traditional | PDF ↗ |
| K040310 | NOVA FAMILY OF MEDICAL RADIOLOGY DISPLAYS | National Display Systems | 2004-06-17 | Traditional | PDF ↗ |
| K040443 | DOME CX DIGITAL FLAT-PANEL DISPLAY SYSTEM, MODEL C5I | Dome Imaging Systems, Inc. | 2004-06-16 | Traditional | PDF ↗ |
| K040697 | 21.3-INCH (54CM) COLOR LCD MONITOR CCL212 (CDL2107A) | Totoku Electric Co., Ltd. | 2004-06-10 | Traditional | PDF ↗ |
| K040746 | MRA-CMS | Medis Medical Imaging Systems BV | 2004-06-08 | Traditional | PDF ↗ |
| K041366 | IPACS ORTHO | Realtimeimage, Inc. | 2004-06-08 | Traditional | PDF ↗ |
| K040695 | 21,3-INCH (54CM) MONOCHROME LCD MONITOR ME213L (MDL2108A) | Totoku Electric Co., Ltd. | 2004-06-07 | Traditional | PDF ↗ |
| K033859 | BARCOVIEW MGD 521M DIGITAL MAMMOGRAPHY DISPLAY | Barco NV Barcoview | 2004-06-02 | Traditional | PDF ↗ |
| K041270 | CT COLONOGRAPHY II | General Electric Medical Systems | 2004-05-27 | Traditional | PDF ↗ |
| K040555 | IMPAX CLIENT EMBRACE | Agfa Corp. | 2004-05-26 | Traditional | PDF ↗ |
| K033849 | SIMPLANT SYSTEM | Materialise NV | 2004-05-25 | Traditional | PDF ↗ |
| K040982 | COLOR LCD MONITOR, MODEL RADIFORCE R12 | Eizo Nanao Corporation | 2004-05-13 | Special | PDF ↗ |
| K040344 | IMPAX OT3000 ORTHOPEDIC WORKSTATION | Agfa Corp. | 2004-05-12 | Traditional | PDF ↗ |
| K033912 | CRADLE PACS | Cradle Technology Corp. | 2004-05-11 | Traditional | PDF ↗ |
| K040376 | SECTRA IDS5 RADIOLOGY WORKSTATION; SECTRA MPR PACKAGE; SECTRA 3D PACKAGE | Sectra-Imtec AB | 2004-05-04 | Special | PDF ↗ |
| K040365 | COLOR CORONIS 2MP MEDICAL FLAT PANEL DISPLAY SYSTEM | Barco N.V. | 2004-04-28 | Traditional | PDF ↗ |
| K040546 | IMAGE-ARENA AND RESEARCH-ARENA APPLICATIONS | Tomtec Imaging Systems GmbH | 2004-04-27 | Traditional | PDF ↗ |
| K033153 | DICOM THEATER | Ferguson Medical | 2004-04-23 | Traditional | PDF ↗ |
| K031661 | 5M MEDICAL FLAT PANEL DISPLAY, ME511L | Totoku Electric Co., Ltd. | 2004-04-23 | Traditional | PDF ↗ |
| K040468 | CEDARA I-SOFTVIEW AND CEDARA I-READMAMMO | Cedara Software Corp. | 2004-04-23 | Special | PDF ↗ |
| K040852 | PREVIEW TREATMENT PLANNING SOFTWARE | Medical Media Systems, Inc. | 2004-04-23 | Special | PDF ↗ |
Product code LLZ · Class II · Radiology. Data: openFDA.