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 12 of 23
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K113739 | SIMPLANT IMMEDIATE SMILE DENTAL CARE SYSTEM | Materialise Dental NV | 2012-05-30 | Traditional | PDF ↗ |
| K121223 | QLAB WITH FHN AND VPQ PLUG-IN | Philips Ultrasound, Inc. | 2012-05-15 | Traditional | PDF ↗ |
| K120637 | SYNAPSE 3D BRAIN PERFUSION | Fujifilm Medical System U.S.A., Inc. | 2012-05-08 | Traditional | PDF ↗ |
| K113599 | SURGICASE CONNECT | Materialise NV | 2012-04-27 | Traditional | PDF ↗ |
| K120207 | VISIA | MeVis Medical Solutions AG | 2012-04-23 | Traditional | PDF ↗ |
| K113240 | 3.7 MP COLOR LCD MONITOR, RADIFORCE MX270W | Eizo Nanao Corporation | 2012-04-20 | Traditional | PDF ↗ |
| K120718 | INSTAPACS/INSTARISPACS | Meddiff Technologies Pvt. , Ltd. | 2012-04-19 | Special | PDF ↗ |
| K120076 | RESOLUTIONMD WEB | Calgary Scientific, Inc. | 2012-04-19 | Traditional | PDF ↗ |
| K120407 | 2MP MONOCHROME LCD MONITOR, RADIFORCE GX240 | Eizo Nanao Corporation | 2012-04-19 | Traditional | PDF ↗ |
| K120196 | OLEA SPHERE | Olea Medical | 2012-04-19 | Traditional | PDF ↗ |
| K120367 | 3MENSIO WORKSTATION | Pie Medical Imaging BV | 2012-04-17 | Traditional | PDF ↗ |
| K120161 | ALPHAPOINT IMAGING SOFTWARE | Radlogics, Inc. | 2012-04-13 | Traditional | PDF ↗ |
| K120135 | 2D CARDIAC PERFORMANCE ANALYSIS MR 1.0 | Tomtec Imaging Systems GmbH | 2012-04-13 | Traditional | PDF ↗ |
| K120315 | SYNGO.MR SPECTRO ENGINE, SYNGO.MR SPECTRO SVS, SYNGO.MR SPECTRO CSI, SYNGO.MR SPECTRO EXTENSION | Siemens Medical Solutions USA, Inc. | 2012-04-13 | Traditional | PDF ↗ |
| K120361 | SYNAPSE 3D BASE TOOLS | Fujifilm Medical Systems U.S.A, Inc. | 2012-04-06 | Traditional | PDF ↗ |
| K120187 | MULTI-MODALITY IMAGE FUSION | Igt, LLC Dba Eigen | 2012-04-06 | Traditional | PDF ↗ |
| K120709 | THE DOME GX4MP COLOR NONITOR | Nds Surgical Imaging | 2012-04-06 | Special | PDF ↗ |
| K120221 | GE ECHOPAC | GE Healthcare | 2012-03-30 | Special | PDF ↗ |
| K120484 | VISIA ONCOLOGY | MeVis Medical Solutions AG | 2012-03-27 | Traditional | PDF ↗ |
| K120115 | ORTHOSIZE | Orthosize, LLC | 2012-03-14 | Traditional | PDF ↗ |
| K120525 | QLAB QUANTIFICATION SOFTWARE | Philips Healthcare Group | 2012-03-09 | Special | PDF ↗ |
| K113082 | SONOVISION | Peridot Technologies Ny, Inc. | 2012-03-08 | Traditional | PDF ↗ |
| K113784 | 3MP MONOCHROME LCD MONITOR, RADIFORCE GX340 | Eizo Nanao Corporation | 2012-03-02 | Traditional | PDF ↗ |
| K113844 | RADIFORCE RX240 | Eizo Nanao Corporation | 2012-02-27 | Traditional | PDF ↗ |
| K112807 | X-RAY VVA | Medis Medical Imaging Systems BV | 2012-02-27 | Traditional | PDF ↗ |
| K112679 | SIMPLANT NAVIGATOR PERSONALIZED DENTAL CARE SYSTEM | Materialise Dental NV | 2012-02-22 | Traditional | PDF ↗ |
| K113442 | 3DI | Shina Systems , Ltd. | 2012-02-16 | Traditional | PDF ↗ |
| K113419 | CS IMAGING | Trophy | 2012-02-16 | Traditional | PDF ↗ |
| K113701 | VISIA NEURO | MeVis Medical Solutions AG | 2012-02-16 | Traditional | PDF ↗ |
| K111758 | CADENS (TM) COLON | Dog Microsystems, Inc. | 2012-02-14 | Traditional | PDF ↗ |
| K111385 | DELL ULTRASHARP U3011 W/QUBYX PERFECTLUM BUNDLE | Qubyx Limited | 2012-01-30 | Traditional | PDF ↗ |
| K113076 | CAAS A-VALVE | Pie Medical Imaging BV | 2012-01-30 | Traditional | PDF ↗ |
| K112720 | MCKESSON HORIZON CARDIOLOGY | Mckesson Israel , Ltd. | 2012-01-30 | Traditional | PDF ↗ |
| K112251 | SWISSMEDA DENTAL PLANNING SYSTEM | Swissmeda AG | 2012-01-25 | Traditional | PDF ↗ |
| K112008 | TOUCHPACS SUITE | Touch Medical Solutions, Inc. | 2012-01-06 | Traditional | PDF ↗ |
| K111861 | SYNGO.MR ONCO, SYNGO.MR 3D LESION SEGMENTATION, SYNGO.MR ONCO ENGINE | Siemens Medical Systems USA | 2012-01-06 | Traditional | PDF ↗ |
| K111776 | DELTAVIEW MODEL 2.1 | Riverain Medical Group,Llc | 2011-12-28 | Traditional | PDF ↗ |
| K112387 | PROCEDURE REHEARSAL STUDIO(TM) | Simbionix , Ltd. | 2011-12-27 | Special | PDF ↗ |
| K113443 | 21.3 INCH (54 CM) MONOCHROME LCD MONITOR MS23I2 (ML21023) | Totoku Electric Co., Ltd. | 2011-12-23 | Traditional | PDF ↗ |
| K112109 | THE KINEGRAPH VMA SOFTWARE, THE MOTION NORMALIZER PATIENT HANDLING AND DATA COLLECTION DEVICE | Ortho Kinematics, Inc. | 2011-12-22 | Traditional | PDF ↗ |
| K113244 | SYNAPSE MPR FUSION | Fujifilm Medical System U.S.A., Inc. | 2011-12-22 | Special | PDF ↗ |
| K113136 | 21.3INCH (54CM)COLOR LCD MONITOR CCL256I2(CL21256) | Totoku Electric Co., Ltd. | 2011-12-20 | Traditional | PDF ↗ |
| K103554 | METRON-CP/MD | Eponatech, LLC | 2011-12-20 | Abbreviated | PDF ↗ |
| K113226 | 8MP COLOR LCD MONITOR,RADIFORCE RX840 | Eizo Nanao Corporation | 2011-12-17 | Traditional | PDF ↗ |
| K113543 | ONDEMAND3D | Cybermed, Inc. | 2011-12-16 | Traditional | PDF ↗ |
| K113541 | CLEARSTART SVM SYSTEM | Intio, Inc. | 2011-12-16 | Traditional | PDF ↗ |
| K112480 | VIEW 1 IMAGING | Karl Storz Endoscopy America, Inc. | 2011-12-13 | Traditional | PDF ↗ |
| K113404 | DENTAL 3D PLANNING SOFTWARE | Symbyo Dental, LLC | 2011-12-06 | Traditional | PDF ↗ |
| K112930 | MOBILE MIM | Mim Software, Inc. | 2011-12-02 | Traditional | PDF ↗ |
| K112354 | 5MP MONOCHROME LCD MONITOR, RADIFORCE GX530 | Eizo Nanao Corporation | 2011-11-30 | Traditional | PDF ↗ |
| K112570 | CENTRICITY CARDIO IMAGING | Ge Healthcare Integrated IT Solutions | 2011-11-30 | Traditional | PDF ↗ |
| K113029 | SYNGO VIA MI WORKFLOWS | Siemens Medical Solutions USA, Inc. | 2011-11-18 | Special | PDF ↗ |
| K111642 | ONCO TRAC MODEL 1, 2, 4 | Translational Sciences Corporation | 2011-11-18 | Traditional | PDF ↗ |
| K110596 | MW100 (MAMMOGRAPHY) LCD MONITOR SYSTEM | Wide Corporation | 2011-11-18 | Traditional | PDF ↗ |
| K112531 | VITREA CT MYOCARDIAL ANALYSIS | Vital Images, Inc. | 2011-11-18 | Traditional | PDF ↗ |
| K112145 | MONOCHROME DIGITAL MAMMOGRAPHY LCD MONITOR MS33I2 | Totoku Electric Co., Ltd. | 2011-11-07 | Traditional | PDF ↗ |
| K110765 | FXA (TM) | Aces GmbH | 2011-11-04 | Traditional | PDF ↗ |
| K111161 | PERFSCAPE V2.0 | Olea Medical | 2011-11-04 | Traditional | PDF ↗ |
| K100784 | UC-CARE NAVIGO SYTEM | UC-CARE , Ltd. | 2011-11-01 | Traditional | PDF ↗ |
| K112604 | 21.3 INCH (54 CM) COLOR LCD MONITOR CCL356I2 (CL21356) | Totoku Electric Co., Ltd. | 2011-10-27 | Traditional | PDF ↗ |
| K112466 | 4MP COLOR LCD MONITOR, RADIFORCERX430 | Eizo Nanao Corporation | 2011-10-27 | Traditional | PDF ↗ |
| K112974 | PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM | Curve Dental, Inc. | 2011-10-20 | Traditional | PDF ↗ |
| K110919 | CARESTREAM PACS | Carestream Health, Inc. | 2011-10-20 | Traditional | PDF ↗ |
| K111990 | CORONIS 5MP | Barco N.V. | 2011-10-17 | Traditional | PDF ↗ |
| K112439 | SYNAPSE WORKSTATION SOFTWARE VERSION 3.3.0 | Fujifilm Medical System U.S.A., Inc. | 2011-10-17 | Traditional | PDF ↗ |
| K112051 | LUNGPOINT PLANNING AND VIRTUAL BRONCHOSCOPIC NAVIGATION (VBN) SOFTWARE | Broncus Technologies, Inc. | 2011-10-12 | Special | PDF ↗ |
| K112530 | 3DI INCLUDING CSCORE | Shina Systems , Ltd. | 2011-09-30 | Traditional | PDF ↗ |
| K112096 | IMAGELINK | Computer Programs and Systems, Inc. | 2011-09-30 | Abbreviated | PDF ↗ |
| K111019 | SURGIMAP (TM) SPINE | Nemaris, Inc. | 2011-09-30 | Traditional | PDF ↗ |
| K111496 | 21.3 INCH (54CM) MONOCHROME DIGITAL MAMMOGRAPHY LCD MONITOR | Totoku Electric Co., Ltd. | 2011-09-26 | Traditional | PDF ↗ |
| K111641 | SURGICASE ORTHOGNATHIC SOFTWARE WIZARD | Materialise NV | 2011-09-26 | Traditional | PDF ↗ |
| K111989 | CORONIS FUSION 4MP DL | Barco N.V. | 2011-09-22 | Special | PDF ↗ |
| K111833 | VIRTUE | Diagnosoft, Inc. | 2011-09-21 | Traditional | PDF ↗ |
| K111731 | MOLECULAR BREAST IMAGING SOFTWARE | Gamma Medica-Ideas Incorporated | 2011-09-15 | Traditional | PDF ↗ |
| K111694 | ASTRA | Candelis, Inc. | 2011-09-15 | Traditional | PDF ↗ |
| K101898 | R4 ACERT ULTRASOUND REPORTING SYSTEM | R4, LLC | 2011-09-15 | Traditional | PDF ↗ |
| K110033 | FEEL-DRCS | Imfou Co., Ltd. | 2011-09-15 | Traditional | PDF ↗ |
| K111660 | XELIS CARDIAC | Infinitt Co., Ltd. | 2011-09-13 | Traditional | PDF ↗ |
| K111346 | RESOLUTIONMD MOBILE MODEL RMB-MOB-2X | Calgary Scientific, Inc. | 2011-09-09 | Traditional | PDF ↗ |
| K111613 | XELIS FUSION | Infinitt Co., Ltd. | 2011-09-08 | Traditional | PDF ↗ |
| K103308 | AIDA HD CONNECT WITH SMARTSCREEN / BLU-RAY DRIVE / SMARTSCREEN WITH BLU-RAY DRIVE | KARL STORZ Endoscopy-America, Inc. | 2011-08-29 | Special | PDF ↗ |
| K103181 | ZENIS, PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM | Genoray Co., Ltd. | 2011-08-26 | Traditional | PDF ↗ |
| K111373 | CT42 CARDIAC COMPUTED TOMOGRAPHY (CT) SOFTWARE | Circle Cardiovascular Imaging, Inc. | 2011-08-23 | Traditional | PDF ↗ |
| K111991 | NIO COLOR 2MP | Barco N.V. | 2011-08-11 | Traditional | PDF ↗ |
| K102078 | RADIOLOGICAL IMAGE PROCESSING SYSTEM | VATECH Co., Ltd. | 2011-08-10 | Traditional | PDF ↗ |
| K111945 | IMPAX NEXT GENERATION | Agfa Healthcare N.V. | 2011-08-05 | Traditional | PDF ↗ |
| K111319 | IBIS EXPLORER AND MARKUP SOFTWARE | Medqia | 2011-08-05 | Traditional | PDF ↗ |
| K111245 | HEARTNAVIGATOR RELEASE 1 | Philips Medical Systems Nederland B.V. | 2011-07-29 | Abbreviated | PDF ↗ |
| K111222 | MRI-Q SYSTEM | Resonance Health Analysis Services Pty, Ltd. | 2011-07-28 | Traditional | PDF ↗ |
| K111892 | VITREAVIEW SOFTWARE 6.1 | Vital Images, Inc. | 2011-07-28 | Traditional | PDF ↗ |
| K111804 | INTELLISPACE PACS 4.X | Philips Healthcare Informatics, Inc. | 2011-07-28 | Traditional | PDF ↗ |
| K103130 | XELIS 3D | Infinitt Co., Ltd. | 2011-07-28 | Traditional | PDF ↗ |
| K110797 | COMMUNIFY PACS VIEWER | Flying Squirrel Storage, LLC | 2011-07-20 | Traditional | PDF ↗ |
| K110300 | SIMPLANT 2011 | Materialise Dental NV | 2011-07-01 | Special | PDF ↗ |
| K110886 | CLIO/CLIOSOFT | Sota Precision Optics, Inc. | 2011-06-30 | Traditional | PDF ↗ |
| K111638 | IMPAX VOLUME VIEWING | Agfa Healthcare N.V. | 2011-06-24 | Traditional | PDF ↗ |
| K110414 | QLAB 8.1 QUANTIFICATION SOFTWARE | Philips Ultrasound, Inc. | 2011-06-21 | Traditional | PDF ↗ |
| K111237 | MD301C4 29.8 DIAGNOSTIC IMAGING LCD MONITOR, L309TY | Nec Display Solutions , Ltd. | 2011-06-15 | Traditional | PDF ↗ |
| K103724 | 10 MP GRAYSCALE FLAT PANEL DISPLAY (GX 1030) | Eizo GmbH | 2011-06-08 | Abbreviated | PDF ↗ |
| K110447 | ECHOINSIGHT | Ultrasound Medical Devices, Inc. | 2011-05-27 | Traditional | PDF ↗ |
Product code LLZ · Class II · Radiology. Data: openFDA.