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 13 of 23
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K102534 | AZE VIRTUALPLACE-MR FLOW ANALYSIS SOFTWARE | Aze, Ltd. | 2011-05-24 | Traditional | PDF ↗ |
| K111336 | EBW NM 2.0 | Philips Medical Systems (Cleveland), Inc. | 2011-05-24 | Traditional | PDF ↗ |
| K111052 | SYNGO NEURO PBV-IR | Siemens Medical Solutions USA, Inc. | 2011-05-20 | Special | PDF ↗ |
| K103723 | SICAT IMPLANT V1.2 | Sicat GmbH & Co. KG | 2011-05-20 | Traditional | PDF ↗ |
| K111079 | SYNGO.VIA WEB VIEWER | Siemens AG Medical Solutions | 2011-05-13 | Traditional | PDF ↗ |
| K110430 | DOLPHIN IMAGING | Patterson Dental Supply, Inc. | 2011-05-11 | Traditional | PDF ↗ |
| K111164 | EUNITY | Client Outlook, Inc. | 2011-05-06 | Traditional | PDF ↗ |
| K110875 | CENTRICITY PACS | GE Healthcare | 2011-05-05 | Traditional | PDF ↗ |
| K111102 | RADIOVISION | Haas Software | 2011-05-05 | Traditional | PDF ↗ |
| K110573 | READY VIEW | Ge Healthcare (Ge Medical Systems Scs) | 2011-05-03 | Traditional | PDF ↗ |
| K110834 | AW VOLUMESHARE 5 WITH ANGIOVIZ OPTION | GE Healthcare | 2011-04-26 | Special | PDF ↗ |
| K110139 | CURVE IMAGE | Curve Dental, Inc. | 2011-04-21 | Traditional | PDF ↗ |
| K111024 | JETPACK 2.0 | Philips Medical Systems (Cleveland), Inc. | 2011-04-21 | Traditional | PDF ↗ |
| K110844 | SYMBIA.NET | Siemens Medical Solutions USA, Inc. | 2011-04-20 | Special | PDF ↗ |
| K103565 | MEDVOXEL HEARTPRO SOFTWARE APPLICATION | Medvoxel Systems, Inc. | 2011-04-12 | Traditional | PDF ↗ |
| K110667 | IMAGE-ARENA AND IMAGE-ARENA APPLICATIONS | Tomtec Imaging Systems GmbH | 2011-04-08 | Traditional | PDF ↗ |
| K110595 | 4D SONO-SCAN 1.0 | Tomtec Imaging Systems GmbH | 2011-04-07 | Traditional | PDF ↗ |
| K110186 | SYNAPSE 3D LIVER ANALYSIS | Fujifilm Medical System U.S.A., Inc. | 2011-04-07 | Traditional | PDF ↗ |
| K110494 | SYNGO MBF | Siemens Medical Solutions USA, Inc. | 2011-04-06 | Special | PDF ↗ |
| K110332 | CLEARCANVAS RIS / PACS | Clearcanvas, Inc. | 2011-03-24 | Traditional | PDF ↗ |
| K103546 | AYCAN WORKSTATION OSIRIX PRO | Aycan Digitalsysteme GmbH | 2011-03-17 | Special | PDF ↗ |
| K110108 | MODALIXX | Ampronix, Inc. | 2011-03-16 | Traditional | PDF ↗ |
| K103720 | SYNAPSE 3D LUNG AND ABDOMEN ANALYSIS | Fujifilm Medical Systems U.S.A, Inc. | 2011-03-16 | Traditional | PDF ↗ |
| K110511 | E4D COMPASS | D4D Technologies | 2011-03-11 | Traditional | PDF ↗ |
| K103480 | THORACIC VCAR | Ge Medical Systems, LLC | 2011-03-07 | Traditional | PDF ↗ |
| K103792 | BARCO MAMMO TOMOSYNTHESIS | Barco N.V. | 2011-03-04 | Traditional | PDF ↗ |
| K103458 | VIEWPOINT 6 | GE Healthcare | 2011-03-04 | Traditional | PDF ↗ |
| K103687 | SYNAPSE 3D CEREBRAL ANALYSIS | Fujifilm Medical System U.S.A., Inc. | 2011-03-04 | Traditional | PDF ↗ |
| K103679 | AXIS PACS, HMS PACS | Axis Health Care, LLC | 2011-03-03 | Traditional | PDF ↗ |
| K103576 | MIM 5.2 (BRACHY) | Mim Software, Inc. | 2011-02-18 | Traditional | PDF ↗ |
| K103761 | VISUALIZE: VASCULAR | The Medipattern Corporation | 2011-02-11 | Traditional | PDF ↗ |
| K103785 | MOBILE MIM | Mim Software, Inc. | 2011-02-04 | Traditional | PDF ↗ |
| K101842 | ACIES | Konica Minolta Medical & Graphic, Inc. | 2011-02-04 | Traditional | PDF ↗ |
| K101398 | STEREOS WORKSTATION | Biospace Med | 2011-02-04 | Traditional | PDF ↗ |
| K103385 | SECURVIEW DX DIAGNOSTIC WORKSTATION | Hologic, Inc. | 2011-02-02 | Special | PDF ↗ |
| K103465 | SYNAPSE 3D CARDIAC TOOLS | Fujifilm Medical Systems U.S.A, Inc. | 2011-01-31 | Traditional | PDF ↗ |
| K110071 | COR ANALYZER | Rcadia Medical Imaging , Ltd. | 2011-01-31 | Special | PDF ↗ |
| K110077 | NEUCOLONCARE | Neusoft Medical Systems Co., Ltd. | 2011-01-28 | Traditional | PDF ↗ |
| K110040 | OMNIVISION | Modern Module, Inc. | 2011-01-26 | Traditional | PDF ↗ |
| K103815 | Q-STATION | Philips Ultrasound, Inc. | 2011-01-25 | Traditional | PDF ↗ |
| K103182 | TRIANA, PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM | Genoray Co., Ltd. | 2011-01-14 | Traditional | PDF ↗ |
| K103475 | SPINEANALYER MODEL SAPOC | Optasia Medical | 2011-01-05 | Traditional | PDF ↗ |
| K100372 | SAFECT MODEL VER 1.0 | Medic Vision Brain Technologies, Ltd. | 2010-12-14 | Traditional | PDF ↗ |
| K100837 | PACENTRIC CONNECT, TRAVELER AND WEB | Fimreite Software AS | 2010-12-03 | Abbreviated | PDF ↗ |
| K102849 | ACCULMAING | Radiology Information Systems, Inc. | 2010-11-23 | Traditional | PDF ↗ |
| K092728 | 20.1 INCH (51 CM) COLOR LCD MONITOR CCL208 (CDL2013A) | Totoku Electric Co., Ltd. | 2010-11-19 | Traditional | PDF ↗ |
| K101654 | IMPROVIS IMAGING SYSTEM | American Dental Partners, Inc. | 2010-11-10 | Traditional | PDF ↗ |
| K101707 | FULACCESS MODEL 1.0 | Fulcrum Medical, Inc. | 2010-10-29 | Traditional | PDF ↗ |
| K102435 | BEYONDIMAGE WORKSTATION | Neusoft Medical Systems Co., Ltd. | 2010-10-15 | Traditional | PDF ↗ |
| K102000 | IMAGYS | Keosys Sas | 2010-10-12 | Traditional | PDF ↗ |
| K102556 | VOLPARA, VERSION 1.3 | Matakina Technology Limited | 2010-10-07 | Traditional | PDF ↗ |
| K101166 | 4D-VIEW 9.1 (4D VIEW PC SOFTWARE) MODEL: H48651SZ | GE Healthcare | 2010-10-07 | Traditional | PDF ↗ |
| K101324 | GE ECHOPAC MODEL BT10 | Ge Vingmed Ultrasound AS | 2010-10-05 | Traditional | PDF ↗ |
| K102150 | SYNGO DYNAMICS, VERSION 9.0 | Siemens Medical Solutions USA, Inc. | 2010-10-05 | Traditional | PDF ↗ |
| K102687 | MIRADA RT | Mirada Medical, Ltd. | 2010-10-04 | Traditional | PDF ↗ |
| K102684 | XELIS DENTAL | Infinitt Co., Ltd. | 2010-10-01 | Traditional | PDF ↗ |
| K101311 | EP NAVIGATOR R3 | Philips Medical Systems North America Co. | 2010-09-30 | Traditional | PDF ↗ |
| K101697 | ENSITE VERISMO SEGMENTATION TOOL V.2.0 | St Jude Medical | 2010-09-22 | Traditional | PDF ↗ |
| K100793 | UROSTATION 3D PROSTATE SUITE | Koelis | 2010-09-22 | Traditional | PDF ↗ |
| K101342 | OSIRIX MD | Pixmeo Sarl | 2010-08-20 | Traditional | PDF ↗ |
| K093269 | PROCEDURE REHEARSAL STUDIO | Simbionix , Ltd. | 2010-08-20 | Traditional | PDF ↗ |
| K102148 | CURIEPACS (DICOM PACS SOFTWARE) | Moksha Digital Software Pvt Limited | 2010-08-17 | Traditional | PDF ↗ |
| K090947 | 21.3 (54 CM) MONOCHROME DIGITAL MAMMOGRAPHY LCD MONITOR, MODEL MS3112 (MDL2128A) | Totoku Electric Co., Ltd. | 2010-08-16 | Traditional | PDF ↗ |
| K101749 | SYNGO TRUED SOFTWARE | Siemens Medical Solutions | 2010-08-16 | Traditional | PDF ↗ |
| K101666 | SYNGO. PLAZA VA20A | Siemens AG Medical Solutions | 2010-08-10 | Traditional | PDF ↗ |
| K101279 | CORRIDOR4DM V2010 MODEL: V2010 | Invia | 2010-08-04 | Traditional | PDF ↗ |
| K101662 | SYNAPSE 3D BASIC TOOLS | Fujifilm Medical System U.S.A., Inc. | 2010-07-26 | Traditional | PDF ↗ |
| K092328 | MED-SEG, MODEL BTMS 1000 | Bartron Medical Imaging, Inc. | 2010-07-26 | Abbreviated | PDF ↗ |
| K101796 | PACSMATE MMD-5201M MONITOR | Iei Technology Corp. | 2010-07-15 | Traditional | PDF ↗ |
| K093197 | CORONIS FUSION 10MP, MODEL MDCG-10130 | Barco N.V. | 2010-06-23 | Traditional | PDF ↗ |
| K101228 | MIRADA XD | Mirada Medical, Ltd. | 2010-06-23 | Traditional | PDF ↗ |
| K092915 | CEDARA WEBACCESS, MODEL: 2.4 | Cedara Software Corp. | 2010-06-23 | Traditional | PDF ↗ |
| K100619 | SYMBIA.NET, SYMBIA.NET SELECT MODEL 10520828, 10520827 | Siemens Medical Solutions USA, Inc. | 2010-05-07 | Special | PDF ↗ |
| K094064 | ILUMA VISION MODEL VERSION 2.2 | 3M Imtec | 2010-04-30 | Traditional | PDF ↗ |
| K100292 | CAAS QVA 3D, CAAS QCA 3D | Pie Medical Imaging BV | 2010-04-30 | Traditional | PDF ↗ |
| K100881 | SYNAPSE OBLIQUUS MIP/MPR/FUSION | Fujifilm Medical System U.S.A., Inc. | 2010-04-14 | Traditional | PDF ↗ |
| K100335 | ORS VISUAL | Object Research Systems, Inc. | 2010-04-08 | Traditional | PDF ↗ |
| K100236 | STAIR SYSTEMS PACS & DICOM VIEWER | Stair Systems, Inc. | 2010-03-29 | Traditional | PDF ↗ |
| K093603 | STORM-BASE 2.0 | KARL STORZ Endoscopy-America, Inc. | 2010-03-18 | Traditional | PDF ↗ |
| K092363 | SOFTVIEW, MODEL 2.01 | Riverain Medical Group | 2010-03-18 | Traditional | PDF ↗ |
| K091631 | ACCESSNET, ACCESSMED, ACCESSRAD, MEDVIEW | Aspyra, Inc. | 2010-03-18 | Traditional | PDF ↗ |
| K092427 | SPINAL GUIDES PACS (PACS MEDICAL IMAGING DISPLAY WORKSTATION) | Albert Davydov Dds PC Professional | 2010-03-16 | Traditional | PDF ↗ |
| K100094 | CARESTREAM IMAGE SUITE | Carestream Heatlh, Inc. | 2010-03-11 | Traditional | PDF ↗ |
| K090050 | STEREOS WORKSTATION | Biospace Med | 2010-03-05 | Traditional | PDF ↗ |
| K093480 | CUATTRO UNOMD | Cuattro, LLC | 2010-03-05 | Traditional | PDF ↗ |
| K093612 | SYNGO.PLAZA | Siemens AG Medical Solutions | 2010-03-04 | Traditional | PDF ↗ |
| K092613 | COLOR LCD MONITOR, MODEL RADIFORCE RS210 | Eizo Nanao Corporation | 2010-03-03 | Special | PDF ↗ |
| K092842 | ECHOPLAQUE | Indec Systems, Inc. | 2010-03-01 | Traditional | PDF ↗ |
| K093621 | SYNGO.PET&CT ONCOLOGY | Siemens Medical Solutions USA, Inc. | 2010-02-23 | Traditional | PDF ↗ |
| K093444 | EXAPACS | Medincom Technology Corp | 2010-02-04 | Traditional | PDF ↗ |
| K093703 | 3DI | Shina Systems , Ltd. | 2010-01-19 | Traditional | PDF ↗ |
| K093355 | PCR ELEVA 1.2 | Philips Medical Systems, Inc. | 2010-01-08 | Special | PDF ↗ |
| K093982 | XELERIS 3 PROCESSING AND REVIEW WORKSTATION | Ge Medical Systems F.I. Haifa | 2010-01-08 | Traditional | PDF ↗ |
| K093090 | GALILEOS IMPLANT, VERSION 1.7 | Sicat GmbH & Co. KG | 2009-12-17 | Traditional | PDF ↗ |
| K093117 | DIGITAL LIGHTBOX | Brainlab AG | 2009-12-11 | Traditional | PDF ↗ |
| K093672 | AEGIS NAVIGATION ANDA EGIS PELVIC APPLICATION | Sentinelle Medical, Inc. | 2009-12-11 | Traditional | PDF ↗ |
| K091364 | DICOMPACS, MODEL 5.2, DICOMPACS DX-R, MODEL 1.4 | Oehm Und Rehbein GmbH | 2009-12-11 | Traditional | PDF ↗ |
| K092125 | PRESIDIO PACS | Reaonix Security, LLC | 2009-12-10 | Traditional | PDF ↗ |
| K093247 | MEDSYNAPSE PACS SOFTWARE | Medsynaptic Private, Ltd. | 2009-12-02 | Traditional | PDF ↗ |
| K092639 | INNOVA VISION, MODEL S18751VN, INNOVA TRACKVISION, MODEL S18751VT, INNOVA EPVISION, MODEL S18751EP | GE Medical Systems SCS | 2009-12-02 | Traditional | PDF ↗ |
Product code LLZ · Class II · Radiology. Data: openFDA.