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 19 of 23
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K033006 | MIVD 1218 18 INCH GREYSCALE LCD DISPLAY MODULE | Barco NV Barcoview | 2004-04-20 | Traditional | PDF ↗ |
| K033104 | MGD 2621P MEDICAL GREYSCALE DISPLAY | Barco NV Barcoview | 2004-04-19 | Traditional | PDF ↗ |
| K040876 | ICONNECTION, VERSION 3.2.0.0 MEDICAL IMAGE PROCESSING SOFTWARE | Vital Images, Inc. | 2004-04-19 | Traditional | PDF ↗ |
| K040126 | VIATRONIX V3D COLON, REVISION 1.3 | Viatronix, Inc. | 2004-04-19 | Traditional | PDF ↗ |
| K033005 | MFGD 1318 18 INCH 1 MEGAPIXEL GREYSCALE LCD DISPLAY | Barco NV Barcoview | 2004-04-19 | Traditional | PDF ↗ |
| K033004 | MFGD 2320 20 INCH 2 MEGAPIXEL GREYSCALE LCD DISPLAY | Barco NV Barcoview | 2004-04-16 | Traditional | PDF ↗ |
| K033103 | MGD 2621L MEDICAL GREYSCALE DISPLAY | Barco NV Barcoview | 2004-04-16 | Traditional | PDF ↗ |
| K040158 | MFCD 2320 | Barco N.V. | 2004-04-12 | Traditional | PDF ↗ |
| K040195 | CALYSTO IMAGE IV-IMAGE AND INFORMATION MANAGEMENT SYSTEM | Witt Biomedical Corp | 2004-04-07 | Traditional | PDF ↗ |
| K040041 | NIO 3MP MEDICAL GRAYSCALE DISPLAY SYSTEM | Barco NV Barcoview | 2004-03-29 | Traditional | PDF ↗ |
| K040399 | QONTRAST | Amid | 2004-03-29 | Traditional | PDF ↗ |
| K040040 | NIO 5MP MEDICAL GRAYSCALE DISPLAY SYSTEM | Barco NV Barcoview | 2004-03-29 | Traditional | PDF ↗ |
| K040050 | INSTATRAK SYSTEM WITH MULTIPLE DATASET NAVIGATION, MODEL IT3500 | Ge Medical Systems Navigation and Visualization IN | 2004-03-24 | Traditional | PDF ↗ |
| K040039 | NIO 2MP MEDICAL GRAYSCALE DISPLAY SYSTEM | Barco N.V. | 2004-03-17 | Traditional | PDF ↗ |
| K033920 | CAAS II RVA | Pie Medical Imaging BV | 2004-03-17 | Traditional | PDF ↗ |
| K033955 | RTIST | Mirada Solutions , Ltd. | 2004-03-17 | Traditional | PDF ↗ |
| K040486 | MEDIPACS | Neobit Co., Ltd. | 2004-03-11 | Traditional | PDF ↗ |
| K034059 | SECTRA ANGIOGRAPHY PACKAGE AND SECTRA CARDIOLOGY PACKAGE | Sectra AB | 2004-03-09 | Traditional | PDF ↗ |
| K032555 | 3M COLOR MEDICAL FLAT PANEL DISPLAY, CCL316 | Totoku Electric Co., Ltd. | 2004-02-26 | Traditional | PDF ↗ |
| K040305 | VITREA2 VERSION 3.5 | Vital Images, Inc. | 2004-02-24 | Traditional | PDF ↗ |
| K033466 | COLOR LCD DISPLAY, MODEL RADIFORCE R22 | Eizo Nanao Corporation | 2004-02-20 | Special | PDF ↗ |
| K040254 | INTEGRIS 3D-RA, RELEASE 4.2 | Philips Medical Systems North America Co. | 2004-02-19 | Traditional | PDF ↗ |
| K040227 | QLAB QUANTIFICATION SOFTWARE | Philips Ultrasound | 2004-02-17 | Traditional | PDF ↗ |
| K040142 | ENSPHERE TEMPO JETSTREAM WORKSPACE CARDIOLOGY MODULE | Adac Laboratories | 2004-02-06 | Traditional | PDF ↗ |
| K033825 | ORTHOPACS | Etrauma.Com Corp. | 2004-02-02 | Traditional | PDF ↗ |
| K032531 | CHASE CARDIAC ANALYSIS SYSTEM | Chase Medical, Inc. | 2004-02-02 | Traditional | PDF ↗ |
| K040028 | CA-1500 | R2 Technology, Inc. | 2004-01-22 | Traditional | PDF ↗ |
| K033712 | MODIFICATION TO SECTRA IDS5 RADIOLOGY WORKSTATION - VERSION 10.1 | Sectra-Imtec AB | 2003-12-23 | Special | PDF ↗ |
| K033831 | SIENET COSMOS | Siemens AG Medical Solutions | 2003-12-19 | Traditional | PDF ↗ |
| K033624 | PACS SOFTWARE SOLUTION 2003 | Canon USA, Inc. | 2003-12-15 | Special | PDF ↗ |
| K033400 | SENO ADVANTAGE | Ge Medical Systems W-400 | 2003-12-04 | Traditional | PDF ↗ |
| K031132 | CONSULTIVA CASE INPUT STATION, MODEL CIS-1 | Eastman Kodak Company | 2003-11-26 | Traditional | PDF ↗ |
| K033013 | MDIFICATION TO MEDIPRIME | Algotec Systems, Ltd. | 2003-11-25 | Special | PDF ↗ |
| K033093 | ECHOCONNEX COMMUNICATOR | Connexmd | 2003-11-05 | Traditional | PDF ↗ |
| K033361 | VIATRONIX V3D VASCULAR, REVISION 1.0 | Viatronix, Inc. | 2003-11-05 | Traditional | PDF ↗ |
| K031473 | RATIONAL IMAGING PACS | Intuitive Imaging Informatics, LLC | 2003-10-30 | Traditional | PDF ↗ |
| K032748 | VITREA2, VERSION 3.4 MEDICAL IMAGE PROCESSING SOFTWARE | Vital Images, Inc. | 2003-10-29 | Abbreviated | PDF ↗ |
| K033088 | SECTRA IDS5 RADIOLOGY WORKSTATION VERSION 10.1 | Sectra AB | 2003-10-29 | Special | PDF ↗ |
| K032546 | HOLOGIC DR IMAGEPRO | Hologic, Inc. | 2003-10-16 | Traditional | PDF ↗ |
| K032533 | INTELEPACS | Intelerad Medical Systems, Inc. | 2003-10-16 | Traditional | PDF ↗ |
| K032186 | AUTOALIGN | Cortechs Labs, Inc. | 2003-10-14 | Abbreviated | PDF ↗ |
| K032924 | RADIODEXTER VERSION 1.0, DEXTROSCOPE, MODEL MK10 AND DEXTROBEAM, MODEL MK3 | Volume Interactions Pte, Ltd. | 2003-10-10 | Special | PDF ↗ |
| K032960 | WIDE 2MP TFT LCD MONITOR SYSTEM IF 1902A | Wide Corporation | 2003-10-08 | Traditional | PDF ↗ |
| K032324 | ECHOENCODER | Icardiogram, Incorporated | 2003-10-02 | Traditional | PDF ↗ |
| K031567 | 3D INVIVO BY CSIST | Chung-Shan Institute of Science and Technology | 2003-10-02 | Traditional | PDF ↗ |
| K031590 | SECTRA ORTHOPEDIC PACKAGE | Sectra-Imtec AB | 2003-10-02 | Traditional | PDF ↗ |
| K032176 | RATTAN IMACS BY RATTAN INFORMATION CORPORATION | Rattan Information Corporation | 2003-09-25 | Traditional | PDF ↗ |
| K032157 | TELEMIS-MEDICAL SOLUTION | Telemis S.A. | 2003-09-24 | Traditional | PDF ↗ |
| K032760 | APAX PACS SYSTEM | Tis, Inc. | 2003-09-17 | Traditional | PDF ↗ |
| K032638 | DOME CX DIGITAL FLAT-PANEL DISPLAY SYSTEM MODEL, C3 COLOR AND C3 GRAY | Planar Systems, Inc. | 2003-09-11 | Traditional | PDF ↗ |
| K032020 | 51CM(20.1INCH) TFT MONOCHROME LCD MONITOR, MU5111BW | Iiyama Corporation | 2003-09-02 | Traditional | PDF ↗ |
| K032026 | LCD MONITOR, RADIFORCE G11, G31, G51 | Eizo Nanao Corporation | 2003-08-27 | Special | PDF ↗ |
| K032483 | VIATRONIX V3D EXPLORER, REVISION 1.2 | Viatronix, Inc. | 2003-08-22 | Traditional | PDF ↗ |
| K032401 | ORTHOVIEW | Omsbar, Ltd. | 2003-08-14 | Traditional | PDF ↗ |
| K031836 | PHILIPS FRESCO RELEASE 1 | Philips Medical Systems North America Co. | 2003-08-14 | Traditional | PDF ↗ |
| K031816 | DVNET MDV-PACS | Dvnet International Technology Co., Ltd. | 2003-08-14 | Traditional | PDF ↗ |
| K031562 | RAMSOFT PACS, MODEL 3.0 | Ramsoft, Inc. | 2003-08-11 | Traditional | PDF ↗ |
| K031778 | PRACTICEBUILDER 1-2-3 | Erad Imagemedical Corp. | 2003-08-07 | Traditional | PDF ↗ |
| K031779 | CADSTREAM | Confirma, Inc. | 2003-08-06 | Traditional | PDF ↗ |
| K032202 | DOME CX DIGITAL FLAT-PANEL DISPLAY SYSTEM, MODELS C2 AND C5I | Planar Systems, Inc. | 2003-08-01 | Traditional | PDF ↗ |
| K031704 | FILMLESS CLINIC | Connect Imaging, Inc. | 2003-07-31 | Abbreviated | PDF ↗ |
| K032174 | WIDE 3MP GRAYSCALE TFT LCD MONITOR IF2103A | Wide Corporation | 2003-07-24 | Traditional | PDF ↗ |
| K031638 | CARDIO VASCULAR INFORMATION ENHANCED WORKSTATION | Electromed Imaging, Inc. | 2003-07-21 | Abbreviated | PDF ↗ |
| K032096 | PHILIPS VIEWFORUM 2003 | Philips Medical Systems | 2003-07-18 | Traditional | PDF ↗ |
| K031929 | 5MP TFT LCD MONITOR SYSTEM IF2105A BY WIDE CORPORATION | Wide Corporation | 2003-07-08 | Traditional | PDF ↗ |
| K031372 | PERSONAL DIGITAL WORKSTATION (PDW); FILM DIGITIZING CAMERA AND DIGITAL WORKSTATION | Maxxvision, LLC | 2003-07-02 | Traditional | PDF ↗ |
| K031886 | SONOVIEW PRO BY MEDISON CO., LTD. | Medison Co., Ltd. | 2003-06-30 | Traditional | PDF ↗ |
| K031311 | INTEGRADWEB BY DYNAMIC IMAGING, INC. | Dynamic Imaging, Inc. | 2003-06-20 | Traditional | PDF ↗ |
| K031248 | CONSULTIVA REPORT STATION, MODEL RS-1 | Miramedica, Inc. | 2003-06-20 | Traditional | PDF ↗ |
| K030751 | IPACS PRISM | Realtimeimage, Inc. | 2003-05-29 | Traditional | PDF ↗ |
| K030781 | KODAK DIRECTVIEW PACS/IMAGE MANAGEMENT SYSTEM, KODAK DIRECTVIEW WORKFLOW MANAGER,KODAK DIRECTVIEW CX/DX, KODAK DIRECTVIB | Eastman Kodak Company | 2003-05-29 | Traditional | PDF ↗ |
| K030728 | FYRELINK VL | Mpacs, LLC | 2003-05-23 | Traditional | PDF ↗ |
| K030347 | 20.1 MONOCHROME LCD MONITOR, RADIFORCE G20 | Eizo Nanao Corporation | 2003-05-02 | Traditional | PDF ↗ |
| K030272 | FLAT PANEL DISPLAY, ME183L | Totoku Electric Co., Ltd. | 2003-04-25 | Traditional | PDF ↗ |
| K030274 | MEDICAL FLAT PANEL DISPLAY, ME315L | Totoku Electric Co., Ltd. | 2003-04-25 | Traditional | PDF ↗ |
| K030276 | FLAT PANEL DISPLAYS, CDL SERIES | Totoku Electric Co., Ltd. | 2003-04-25 | Traditional | PDF ↗ |
| K031013 | INFINTT CO., LTD. STARPACS SYSTEM | Infinitt Company | 2003-04-17 | Special | PDF ↗ |
| K030457 | REX, VERSION 3.0 | Pointdx, Inc. | 2003-04-08 | Traditional | PDF ↗ |
| K030982 | SYNGO COLONOGRAPHY SOFTWARE PACKAGE | Siemens Medical Solutions USA, Inc. | 2003-04-08 | Traditional | PDF ↗ |
| K030635 | THE OBSIDIAN PACS SYSTEM | Obsidian Medical Technology, Inc. | 2003-03-28 | Traditional | PDF ↗ |
| K030363 | ORG@NIZER, MODEL VERSION 3.0 | Ebit Sanita, S.P.A. | 2003-03-27 | Traditional | PDF ↗ |
| K024358 | 20.1 MONOCHROME LCD MONITOR, RADIFORCE G21 | Eizo Nanao Corporation | 2003-03-25 | Traditional | PDF ↗ |
| K024159 | STRYKERWARE SYSTEM | Stryker Endoscopy | 2003-03-10 | Traditional | PDF ↗ |
| K030242 | FYRELINK | Mpacs, LLC | 2003-03-10 | Traditional | PDF ↗ |
| K030223 | SONOCALC | Sonometric Health, LLC | 2003-02-06 | Traditional | PDF ↗ |
| K022877 | OBSERVER ULTRASOUND REPORTING AND IMAGING SYSTEM | Vision Chips, Inc. | 2003-02-05 | Traditional | PDF ↗ |
| K024028 | SHARP VIEW IMAGE ENHANCEMENT SYSTEM | Context Vision AB | 2003-01-24 | Traditional | PDF ↗ |
| K024103 | IVUS PLUS | Indec Systems, Inc. | 2003-01-24 | Traditional | PDF ↗ |
| K023533 | BARCO MEDIS 5MP2 AURA | Barco N.V. | 2003-01-17 | Traditional | PDF ↗ |
| K024137 | JUPITER PROCESSING AND REVIEW WORKSTATION | Ge Medical Systems, Inc. | 2003-01-15 | Special | PDF ↗ |
| K023460 | PACSPLUS | Medical Standard Co., Ltd. | 2003-01-09 | Traditional | PDF ↗ |
| K023394 | UNISIGHT SYSTEM WITH UNIGATE | Electronic Business Machine Co., Ltd. (Ebm) | 2003-01-07 | Abbreviated | PDF ↗ |
| K023467 | HCP DICOM NET | Softlink International, Inc. | 2003-01-07 | Traditional | PDF ↗ |
| K023476 | UNIPACS WORKSTATION | Universal Pacs, Inc. | 2003-01-07 | Traditional | PDF ↗ |
| K023340 | CORONIS 1MP MEDICAL FLAT PANEL DISPLAY SYSTEM | Barco N.V. | 2002-12-23 | Traditional | PDF ↗ |
| K023322 | CORONIS 2MP MEDICAL FLAT PANEL DISPLAY SYSTEM | Barco N.V. | 2002-12-23 | Traditional | PDF ↗ |
| K023341 | CORNIS 5MP MEDICAL FLAT PANEL DISPLAY SYSTEM | Barco N.V. | 2002-12-23 | Traditional | PDF ↗ |
| K023246 | AMALGA PACS | Global Care Solutions, S.A. | 2002-12-23 | Traditional | PDF ↗ |
| K023877 | Q LAB QUANTIFICATION SOFTWARE WITH STRAIN RATE QUANTIFICATION PLUG-IN | Philips Ultrasound, Inc. | 2002-12-23 | Traditional | PDF ↗ |
| K023339 | IMAGETILE | Barco N.V. | 2002-12-23 | Traditional | PDF ↗ |
Product code LLZ · Class II · Radiology. Data: openFDA.