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 21 of 23
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K002424 | 3D ANGIOGRAPHIC IMAGING SYSTEM, MODEL XIDF-100A | Toshiba America Medical Systems, In.C | 2000-10-27 | Traditional | PDF ↗ |
| K002519 | VITREA 2, VERSION 2.1 | Vital Images, Inc. | 2000-10-19 | Traditional | PDF ↗ |
| K002936 | MODIFICATION TO IDS5 IMAGE DISPLAY SYSTEM | Sectra-Imtec AB | 2000-10-17 | Special | PDF ↗ |
| K002144 | MEDLINK DIAGNOSTIC OFFLINE WORKSTATION | Advanced Technology Laboratories, Inc. | 2000-09-28 | Traditional | PDF ↗ |
| K002039 | ECAT PET SCANNER, MODELS ECAT EXACT AND ECAT EXACT HR+ AND ECAT ART | Cti Pet Systems, Inc. | 2000-09-27 | Traditional | PDF ↗ |
| K002100 | XIMX SYSTEM | Medical Manager Research Development | 2000-08-25 | Traditional | PDF ↗ |
| K001753 | MEDIS 5MP2 DUAL-HEAD MEDICAL DIAGNOSTIC DISPLAY SYSTEM | Barco NV Display Systems | 2000-07-27 | Traditional | PDF ↗ |
| K001748 | MEDIS 5MP2 QUAD-HEAD MEDICAL DIAGNOSTIC DISPLAY SYSTEM | Barco NV Display Systems | 2000-07-27 | Traditional | PDF ↗ |
| K001750 | MEDIS 5MP1H QUAD-HEAD MEDICIAL DIAGNOSTIC DISPLAY SYSTEM | Barco NV Display Systems | 2000-07-21 | Traditional | PDF ↗ |
| K001751 | MEDIS 2MP2 QUAD-HEAD MEDICAL DIAGNOSTIC DISPLAY SYSTEM | Barco NV Display Systems | 2000-07-19 | Traditional | PDF ↗ |
| K001752 | MEDIS 55MP1H SINGLE-HEAD MEDICAL DIAGNOSTIC DISPLAY SYSTEM | Barco NV Display Systems | 2000-07-19 | Traditional | PDF ↗ |
| K001754 | MEDIS 5MP1H DUAL-HEAD MEDICAL DIAGNOSTIC DISPLAY SYSTEM | Barco NV Display Systems | 2000-07-19 | Traditional | PDF ↗ |
| K001747 | MEDIS 2MP2 DUAL-HEAD MEDICAL DIAGNOSTIC DISPLAY SYSTEM | Barco NV Display Systems | 2000-07-13 | Traditional | PDF ↗ |
| K001596 | LIFERX | Bowdengs Technologies, LLC | 2000-07-06 | Traditional | PDF ↗ |
| K001012 | DIGITAL INTEGRATION SYSTEM, DIS2000 | Wellington Medical Systems, Inc. | 2000-06-13 | Traditional | PDF ↗ |
| K000770 | PROVIEW MEDICAL IMAGE DISPLAY MODULE | Cerner Corp. | 2000-05-16 | Traditional | PDF ↗ |
| K000630 | MODELS PRIAM (FAMILY OF DEVICES) DIGITAL IMAGING SYSTEM | Hopkins Imaging Systems, Inc. | 2000-05-12 | Traditional | PDF ↗ |
| K000395 | EINSTEIN PROCESSING AND REVIEW WORKSTATION | Ge Medical Systems F.I. Haifa | 2000-05-03 | Traditional | PDF ↗ |
| K001140 | IDS5 IMAGE DISPLAY SYSTEM | Sectra AB | 2000-05-03 | Special | PDF ↗ |
| K000380 | FOTOMASTER | Hamilton Thorne Research | 2000-05-03 | Traditional | PDF ↗ |
| K000557 | MEDVIZER PACS, MODEL RELEASE 2000 | Vitel Net | 2000-04-24 | Traditional | PDF ↗ |
| K000443 | REMOTE FETAL MEDICINE ULTRASOUND SYSTEM | R4 Telemedicine, Inc. | 2000-04-24 | Traditional | PDF ↗ |
| K000448 | PACSSTATION | Fernandez Industries, Inc. | 2000-04-20 | Traditional | PDF ↗ |
| K000474 | VIEW NT | Electromed Intl., Ltd. | 2000-04-19 | Abbreviated | PDF ↗ |
| K000292 | BARCO MWD 321 PLUS MEDICAL WORKSTATION DISPLAY | Barco N.V. | 2000-03-29 | Traditional | PDF ↗ |
| K000293 | BARCO MGD 221 2 MEGAPIXEL DIAGNOSTIC DISPLAY | Barco N.V. | 2000-03-29 | Traditional | PDF ↗ |
| K000294 | MFCD 120 | Barco N.V. | 2000-03-27 | Traditional | PDF ↗ |
| K000291 | MFCD 118 | Barco N.V. | 2000-03-27 | Traditional | PDF ↗ |
| K000016 | BARCOMED 5MP2 | Barco N.V. | 2000-03-14 | Traditional | PDF ↗ |
| K000014 | BARCOMED 5MP1H | Barco N.V. | 2000-03-14 | Traditional | PDF ↗ |
| K994270 | INSTATRAK 3000 SYSTEM WITH FLUOROTRAK MODULE, MODEL IT3000 | Visualization Technology, Inc. | 2000-03-09 | Traditional | PDF ↗ |
| K993946 | PEGASYS ULTRA | Adac Laboratories | 2000-03-09 | Traditional | PDF ↗ |
| K994228 | REMOTEIMAGE SYSTEM | Etrauma.Com Corp. | 2000-02-22 | Traditional | PDF ↗ |
| K994054 | ISSA PHAROS | Vams Tec, D.O.O. | 2000-02-14 | Traditional | PDF ↗ |
| K994210 | INTURIS SUITE | Philips Medical Systems, Inc. | 2000-02-04 | Traditional | PDF ↗ |
| K000015 | BARCOMED 2MP2 | Barco N.V. | 2000-02-04 | Traditional | PDF ↗ |
| K993750 | PROSOLV ECHOVIEWER, PROSOLV ECHOVIEWER SE, PROSOLV ECHOANALYZER, PROSOLV ECHOSERV, PROSOLV ECHO | Problem Solving Concepts, Inc. | 2000-02-02 | Traditional | PDF ↗ |
| K993802 | SHARPVIEW IMAGE ENHANCEMENT SYSTEM | Context Vision AB | 2000-01-18 | Traditional | PDF ↗ |
| K993338 | INTEGRATED DIGITAL MEDICAL RECORD (IDMR) | Ibm Israel , Ltd. | 1999-12-29 | Traditional | PDF ↗ |
| K993283 | OSCAR NET/CD, MODEL M1.82 600 . O/A/B/C | Arnold & Richter Cine Technik | 1999-12-29 | Traditional | PDF ↗ |
| K993761 | CARDIOVASCULAR MEASUREMENT SYSTEM - VIEW | Medis Medical Imaging Systems BV | 1999-12-28 | Traditional | PDF ↗ |
| K993227 | PHILIPS INTURIS DICOM RECORDER | Philips Medical Systems North America, Inc. | 1999-12-21 | Traditional | PDF ↗ |
| K993532 | DDS, DS3000, RS3000, CS5000, OT3000, IS3000, RS5000, CD3000, US3000, (AMONGST OTHER NAMES) | Impax Technology, Inc. | 1999-12-15 | Traditional | PDF ↗ |
| K993530 | SYSTEM 2100 | Math Solutions, LLC | 1999-12-15 | Traditional | PDF ↗ |
| K992925 | AX WORKSTATION DR-VIEWER SOFTWARE OPTION | Siemens Corp. | 1999-11-23 | Traditional | PDF ↗ |
| K992886 | POWERVIEW ULTRASOUND WORKSTATION, UIDM-400A | Toshiba America Medical Systems, In.C | 1999-11-09 | Traditional | PDF ↗ |
| K992654 | PLUG 'N VIEW 3D, VERSION 1.0 | Voxar Limited | 1999-11-05 | Traditional | PDF ↗ |
| K992666 | VIDEO PLUS SYSTEM, SERIES 95000 | Camtronics, Ltd. | 1999-10-13 | Traditional | PDF ↗ |
| K992354 | SNT IMAGE ANALYSIS SYSTEM | Surgical Navigation Technologies, Inc. | 1999-10-12 | Traditional | PDF ↗ |
| K992575 | CARDIOVASCULAR WORKSTATION, MODEL CWS 5000/CWS 3000 | Infimed, Inc. | 1999-10-07 | Traditional | PDF ↗ |
| K990241 | ACCUIMAGE, ACCUVIEW DIAGNOSTIC IMAGING, WORKSTATION W/ACCUSCORE, ACCUANALYZE, ACCUSCOPE, ACCUSHADE, ACCUVRT, AND ACCUMIP | Accuimage Diagnostics Corp. | 1999-09-23 | Traditional | PDF ↗ |
| K992306 | SAMSUNG RAYPAX DISPLAY WORKSTATION | Samsung Sds Co., Ltd. | 1999-09-22 | Traditional | PDF ↗ |
| K992112 | SAMSUNG RAYPAX FILM DIGITIZER | Samsung Sds Co., Ltd. | 1999-09-09 | Traditional | PDF ↗ |
| K992073 | AX WORKSTATION | Siemens Medical Solutions USA, Inc. | 1999-09-09 | Traditional | PDF ↗ |
| K992259 | ECHOCARDIOGRAPHY SYSTEM SERIES 95000 | Camtronics, Ltd. | 1999-09-08 | Traditional | PDF ↗ |
| K991738 | DIGITAL VIDEO RECORDING SYSTEM | Kay Elemetrics Corp. | 1999-08-13 | Traditional | PDF ↗ |
| K991629 | GE VIEW APPLICATIONS (CONSISTING OF GE VIEWING STATION AND GE EXTENDED VIEWING STATION) VERSION 1.2C | Ge Medical Systems, Inc. | 1999-08-02 | Traditional | PDF ↗ |
| K991468 | IMMERGE IMAGE CORRELATION | Surgical Navigation Technologies, Inc. | 1999-07-06 | Traditional | PDF ↗ |
| K991626 | WEBRAD COMPUTED RADIOGRAPHY QUALITY ASSURANCE WORKSTATION | Analogic Corp. | 1999-07-02 | Special | PDF ↗ |
| K991257 | FUJI WAVELET COMPRESSION OR FFCOMP IRREVERSIBLE COMPRESSION | Fujifilm Medical System U.S.A., Inc. | 1999-06-25 | Traditional | PDF ↗ |
| K991643 | IDS4 V3.2 IMAGE DISPLAY SYSTEM | O Tech, Inc. | 1999-06-08 | Special | PDF ↗ |
| K991578 | SMARTSPOT 2000 | Cmt Medical Technologies, Ltd. | 1999-06-03 | Special | PDF ↗ |
| K990455 | PHILIPS EASY VISION FAMILY WORKSTATION LEGS OPTION | Philips Medical Systems, Inc. | 1999-05-12 | Traditional | PDF ↗ |
| K990442 | ADVANCED DIAGNOSTIC VIEWER (AOX), MODEL VITRED 1.3 | Vital Images, Inc. | 1999-05-11 | Traditional | PDF ↗ |
| K990919 | STRAIGHT ASPIRATOR, 90 DEGREE ASPIRATOR,45 DEGREE ASPIRATOR,7 FRENCH ASPIRATOR,EXTENDED STRAIGHT ASPIRATOR,13.9 CM STRAG | Visualization Technology, Inc. | 1999-04-15 | Special | PDF ↗ |
| K990759 | VIEW COM | Electromed Intl., Ltd. | 1999-04-15 | Abbreviated | PDF ↗ |
| K990052 | TEL-ECHO SYSTEM | Innovative Medical Solutions, Inc. | 1999-02-19 | Traditional | PDF ↗ |
| K984215 | WELCH ALLYN FRONT-LINE DOC | Welch Allyn, Inc. | 1999-02-11 | Traditional | PDF ↗ |
| K983815 | PACSCACHE | Dome Imaging Systems, Inc. | 1999-01-14 | Traditional | PDF ↗ |
| K983529 | INSTATRAK 3000 | Visualization Technology, Inc. | 1998-12-31 | Traditional | PDF ↗ |
| K982535 | INSIGHT DIAGNOSTIC IMAGING WORKSTATION | Neo Imagery Technologies, Inc. | 1998-12-21 | Traditional | PDF ↗ |
| K983401 | FRAMEWAVE WEB | Ml Strategies, Inc. | 1998-12-15 | Traditional | PDF ↗ |
| K983392 | DATA RAY CORPORATION DR11021 MEDICAL IMAGING MONITOR | Data Ray | 1998-12-15 | Traditional | PDF ↗ |
| K983256 | ADVANTAGE WINDOWS (AW) FUSION | GE Medical Systems | 1998-12-15 | Traditional | PDF ↗ |
| K983821 | PHILIPS INTURIS CARDIO IMAGE VIEWING PACKAGE | Philips Medical Systems North America, Inc. | 1998-12-11 | Traditional | PDF ↗ |
| K984023 | MAXVIEW DIAGNOSTIC WORKSTATION | Dynamic Healthcare Technologies, Inc. | 1998-12-08 | Special | PDF ↗ |
| K982976 | ULTRASOUND WORKSTATION, UIWS-300A | Toshiba America Medical Systems, In.C | 1998-11-24 | Traditional | PDF ↗ |
| K982994 | SKULL BASE INSTATRAK SYSTEM | Visualization Technology, Inc. | 1998-11-16 | Traditional | PDF ↗ |
| K983111 | XRAY VISION | Apteryx, Inc. | 1998-11-16 | Traditional | PDF ↗ |
| K982769 | MITRA IMAGING INC. EXHIBIT | Mitra Imaging, Inc. | 1998-11-03 | Traditional | PDF ↗ |
| K982862 | RADWORKS MEDICAL IMAGING SOFTWARE WITH QUALITY CONTROL MODULE | Applicare Medical Imaging, B.V. | 1998-10-21 | Traditional | PDF ↗ |
| K982820 | BARCO MEDIS 5MP 5 MEGAPIXEL MEDICAL DIAGNOSTIC DISPLAY SYSTEM | Barco NV Display Systems | 1998-10-08 | Traditional | PDF ↗ |
| K982563 | ULTRAPRO MODEL 98 | Ramsoft, Inc. | 1998-10-06 | Traditional | PDF ↗ |
| K982690 | BARCO MEDICAL DISPLAY CONFORMITY AND CONSISTENCY SOFTWARE | Barco N.V. | 1998-10-06 | Traditional | PDF ↗ |
| K982422 | EAGLESOFT CHAIRSIDE | Eaglesoft, A Patterson Co. | 1998-09-30 | Traditional | PDF ↗ |
| K983088 | INSTACINE D-2000 | Fidelity Medical, Inc. | 1998-09-22 | Special | PDF ↗ |
| K982146 | PICTOOLS MEDICAL TOOL KIT MODEL 1.0 | Pegasus Imaging Corp. | 1998-09-14 | Traditional | PDF ↗ |
| K982120 | DIGITAL IMAGING SYSTEM, MODELS DIGITREX-1000 AND DIGITREX-2000 (DIGITREX-X000 FAMILY) | Trex Medical Corp. | 1998-09-10 | Traditional | PDF ↗ |
| K981998 | PEDIATRIC INSTATRAK SYSTEM | Visualization Technology, Inc. | 1998-08-21 | Traditional | PDF ↗ |
| K980648 | PRO VISION | Algotec Systems, Ltd. | 1998-07-20 | Traditional | PDF ↗ |
| K981217 | PLATINUM READING, REVIEW & ANALYSIS WORKSTATION | GE Medical Systems | 1998-06-18 | Traditional | PDF ↗ |
| K980234 | THE NETWORK SYSTEM | Medical Sni , Ltd. | 1998-06-17 | Traditional | PDF ↗ |
| K980970 | IIRAD DIRECTRAY OPERATOR CONSOLE | Sterling Diagnostic Imaging, Inc. | 1998-06-08 | Traditional | PDF ↗ |
| K980168 | COMPUTED RADIOGRAPHY QUALITY ASSURANCE SOFTWARE | Analogic Corp. | 1998-04-02 | Traditional | PDF ↗ |
| K980118 | KODAK DIGITAL SCIENCE ONCOLOGY IMAGE MANAGER | Eastman Kodak Company | 1998-03-17 | Traditional | PDF ↗ |
| K974755 | DYNA VUE 3-D IMAGING PRODUCT | Imd Systems, Inc. | 1998-03-04 | Traditional | PDF ↗ |
| K974504 | EPS | E For M Imaging Systems Div., Marquette Electronic | 1998-02-27 | Traditional | PDF ↗ |
| K980060 | ECHOLINK | Mpacs, LLC | 1998-02-25 | Traditional | PDF ↗ |
| K974474 | PEGASYS INTOUCH | Adac Laboratories | 1998-02-24 | Traditional | PDF ↗ |
| K971965 | PHILIPS EASYVISION | Philips Medical Systems, Inc. | 1998-01-30 | Traditional | PDF ↗ |
Product code LLZ · Class II · Radiology. Data: openFDA.