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 10 of 23
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K141137 | STEREOS WORKSTATION | Eos Imaging | 2014-09-15 | Traditional | PDF ↗ |
| K141514 | SYNAPSE 3D TENSOR ANALYSIS | Fujifilm Meidcal Systems U.S.A.,Inc. | 2014-09-03 | Traditional | PDF ↗ |
| K141364 | CLIMB MAMMOGRAPHY VIEWER SOFTWARE | Climb Medical Systems, Inc. | 2014-08-29 | Traditional | PDF ↗ |
| K141451 | VixWin Platinum | Imaging Sciences International (Dba Gendex, LLC) | 2014-08-26 | Traditional | PDF ↗ |
| K141480 | CVI42 | Circle Cardiovascular Imaging, Inc. | 2014-08-22 | Traditional | PDF ↗ |
| K131348 | ORTOMED | Infomed Servicios Informaticos S.L. | 2014-08-05 | Abbreviated | PDF ↗ |
| K141302 | VITREA CT MULTI-CHAMBER CARDIAC FUNCTIONAL ANALYSIS (CFA) | Vital Images, Inc. | 2014-08-01 | Traditional | PDF ↗ |
| K141061 | REMOTEYE VIEWER | Neologica S.R.L. | 2014-08-01 | Traditional | PDF ↗ |
| K141475 | ENDOSIZE | Therenva Sas | 2014-07-31 | Traditional | PDF ↗ |
| K140897 | SYNGO.MR NEUROLOGY, SYNGO.MMR GENERAL | Siemens Medical Solutions USA, Inc. | 2014-07-18 | Traditional | PDF ↗ |
| K141554 | ESIE APPS SUITE | Siemens Medical Solutions USA, Inc. | 2014-07-11 | Traditional | PDF ↗ |
| K140869 | DCAS I | Gp&P Co., Ltd. | 2014-07-03 | Traditional | PDF ↗ |
| K141556 | AVREO INTERWORKS SYSTEM | Avreo, Inc. | 2014-07-02 | Special | PDF ↗ |
| K140909 | MCKESSON RADIOLOGY | Mckesson Medical Imaging Company | 2014-07-02 | Traditional | PDF ↗ |
| K140819 | SURGICAL NAVIGATION ADVANCED PLATFORM | Surgical Theater, LLC | 2014-06-27 | Traditional | PDF ↗ |
| K141329 | RADSPA | Telerad Tech Private Limited | 2014-06-20 | Abbreviated | PDF ↗ |
| K141199 | QUENTRY DOSE REVIEW | Brainlab AG | 2014-06-20 | Traditional | PDF ↗ |
| K140713 | PLANMECA ROMEXIS | Planmeca Oy | 2014-06-16 | Traditional | PDF ↗ |
| K133098 | SENYINT PACS | Dalian Senyint Digital Medical System Co., Ltd. | 2014-06-13 | Traditional | PDF ↗ |
| K140960 | PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM | Hologic, Inc. | 2014-06-13 | Traditional | PDF ↗ |
| K140434 | MEDICAD CLASSIC | Hectec GmbH | 2014-06-05 | Traditional | PDF ↗ |
| K140337 | BRIGHTMATTER PLANNING SOFTWARE | Synaptive Medical, Inc. | 2014-06-02 | Traditional | PDF ↗ |
| K140139 | CLEARVIEWHD | Clearview Diagnostics, Inc. | 2014-05-28 | Traditional | PDF ↗ |
| K132684 | MEDWS SOFTWARE (VARIANTS MEDVIEW, MEDDIAG, MEDMAMMO) | Medecom Sarl | 2014-05-23 | Abbreviated | PDF ↗ |
| K140395 | VITREA IMAGE DENOISING SOFTWARE | Vital Images, Inc. | 2014-05-13 | Traditional | PDF ↗ |
| K140445 | DEXIS SOFTWARE: DEXIS IMAGING SUITE, DEXIS MAC | Imaging Sciences International, LLC | 2014-04-23 | Special | PDF ↗ |
| K140808 | Q-STATION | Philips Ultrasound, Inc. | 2014-04-17 | Traditional | PDF ↗ |
| K133521 | AZE PHOENIX SOFTWARE | Aze, Ltd. | 2014-04-11 | Traditional | PDF ↗ |
| K133910 | NORDICBRAINEX | Nordicneurolab | 2014-04-04 | Traditional | PDF ↗ |
| K140271 | TABLET VIEWER SOFTWARE FOR IMAGE SUITE | Carestream Health, Inc. | 2014-04-01 | Traditional | PDF ↗ |
| K133984 | CORONIS 5MP | Barco N.V. | 2014-03-28 | Traditional | PDF ↗ |
| K133508 | RESOLUTIONMD MOBILE | Calgary Scientific, Inc. | 2014-03-26 | Traditional | PDF ↗ |
| K133663 | NIO COLOR 2MP | Barco N.V. | 2014-03-25 | Traditional | PDF ↗ |
| K133401 | SYNO MR NEUROLOGY, SYNGO MR ONCOLOGY, SYNGO. MR BREVIS, SYNGO MMR GENERAL | Siemens Medical Solutions USA, Inc. | 2014-03-11 | Traditional | PDF ↗ |
| K140093 | TABLE | Anatomage, Inc. | 2014-03-07 | Traditional | PDF ↗ |
| K133135 | IMPAX VOLUME VIEWING 3.0 | Agfa Healthcare N.V. | 2014-03-07 | Traditional | PDF ↗ |
| K133022 | ZEDVIEW | Lexi Co., Ltd. | 2014-03-06 | Traditional | PDF ↗ |
| K133966 | MODEL-BASED RSA SOFTWARE | Halifax Biomedical, Inc. | 2014-03-06 | Traditional | PDF ↗ |
| K133937 | HEARTSCAN SOFTWARE | Morpheus Imaging, Inc. | 2014-03-03 | Traditional | PDF ↗ |
| K133654 | SCENIUM | Siemens Medical Solutions USA, Inc. | 2014-02-28 | Traditional | PDF ↗ |
| K133609 | THE DOME S6C | Nds Surgical Imaging | 2014-02-28 | Special | PDF ↗ |
| K132763 | ADVANCED VIEWER | Brainlab AG | 2014-02-28 | Traditional | PDF ↗ |
| K140033 | TARGET3D FUSION | Convergent Life Sciences, Inc. | 2014-02-27 | Traditional | PDF ↗ |
| K133385 | LUNGPOINT ATV PLANNING AND NAVIGATION SOFTWARE | Broncus Medical, Inc. | 2014-02-26 | Traditional | PDF ↗ |
| K133644 | SYNGO.VIA MI WORKFLOWS | Siemens Medical Solutions USA, Inc. | 2014-02-25 | Traditional | PDF ↗ |
| K133320 | SICAT FUNCTION | Sicat GmbH & Co. KG | 2014-02-25 | Traditional | PDF ↗ |
| K140214 | 30.0 INCH COLOR LCD MONITOR CCL650I2 (CL30650, MD302C6) | Jvckenwood Corporation | 2014-02-19 | Traditional | PDF ↗ |
| K133708 | MD302C4 29.8 DIAGNOSTIC IMAGING LCD MONITOR | Nec Display Solutions , Ltd. | 2014-02-14 | Traditional | PDF ↗ |
| K140108 | 3MP COLOR LCD DISPLAY | Shenzhen Beacon Display Technology Co., Ltd. | 2014-02-14 | Traditional | PDF ↗ |
| K140103 | 3MP GRAYSCAKE LCD DISPLAY | Shenzhen Beacon Display Technology Co., Ltd. | 2014-02-14 | Traditional | PDF ↗ |
| K132824 | CARESTREAM VUE PACS VERSION 11.4 CARESTREAM VUE MOTION APPLICATION | Carestream Health, Inc. | 2014-02-06 | Traditional | PDF ↗ |
| K134002 | 6MP COLOR LCD MONITOR, RADIFORCE RX650 | Eizo Corporation | 2014-01-31 | Traditional | PDF ↗ |
| K133730 | CO PILOT/REGIUS UNITEA | Konica Minolta, Inc. | 2014-01-31 | Traditional | PDF ↗ |
| K132770 | DOME S10 | Nds Surgical Imaging | 2014-01-30 | Traditional | PDF ↗ |
| K133030 | DYNACAD/PROSTATE INTERVENTIONAL (DYNALOC/PROSTATE) | Invivo Corporation | 2014-01-22 | Traditional | PDF ↗ |
| K132499 | ICRCO CLARITY VIEWER | Icrco, Inc. | 2014-01-21 | Traditional | PDF ↗ |
| K133875 | THE KINEGRAPH VMA (VERTEBRAL MOTION ANALYZER) SOFTWARE VERSION 2.2, THE MOTION NORMALIZER PATIENT HANDLING AND DATA | Ortho Kinematics, Inc. | 2014-01-17 | Special | PDF ↗ |
| K133686 | 21.3 INCH (54 CM) INCH MONOCHROME DIGITAL MAMMOGRAPHY LCD MONITOR MS35i2 (ML21035) | Jvckenwood Corporation | 2014-01-06 | Traditional | PDF ↗ |
| K130998 | SYNGO.VIA WEB VIEWER | Siemens AG Medical Solutions | 2014-01-03 | Traditional | PDF ↗ |
| K132095 | OLEA SPHERE | Olea Medical | 2013-12-26 | Traditional | PDF ↗ |
| K131447 | INTUITION - TDA, TVA, PARAMETRIC MAPPING | Terarecon,Inc. | 2013-12-24 | Traditional | PDF ↗ |
| K132342 | XVWEB | Apteryx, Inc. | 2013-12-20 | Traditional | PDF ↗ |
| K133367 | ORTHOVIS PREOPERATIVE PLAN | Custom Orthopaedic Solutions | 2013-12-20 | Traditional | PDF ↗ |
| K133511 | 21.3 INCH(54 CM) MONOCHROME LCD MONITOR MS25I2(ML21025) | Jvckenwood Corporation | 2013-12-19 | Traditional | PDF ↗ |
| K132963 | FUSIONSYNC, CHIMAERA FUSIONSYNC | Chimaera GmbH | 2013-12-16 | Traditional | PDF ↗ |
| K132773 | SIDEXIS 4 | Sirona Dental Systems GmbH | 2013-12-11 | Traditional | PDF ↗ |
| K132532 | SYNGO.PLAZA VB10A | Siemens AG Healthcare | 2013-12-09 | Traditional | PDF ↗ |
| K132742 | M-VU BREAST DENSITY | Vucomp, Inc. | 2013-12-03 | Traditional | PDF ↗ |
| K133185 | 21.3 INCH (54 CM) COLOR LCD MONITOR CCL358I2 (CL21358) | Jvckenwood Corporation | 2013-12-03 | Traditional | PDF ↗ |
| K133181 | 21.3 INCH (54 CM) COLOR LCD MONITOR CCL258I2 (CL21258) | Jvckenwood Corporation | 2013-12-03 | Traditional | PDF ↗ |
| K131390 | JUSHA-M52C MEDICAL DISPLAY | Nanjing Jusha Display Technology Co., Ltd. | 2013-11-27 | Traditional | PDF ↗ |
| K132544 | TOMTEC-ARENA 1.0, TOMTEC-ARENA 3D ECHO, CARDIO-ARENA | Tomtec Imaging Systems GmbH | 2013-11-25 | Traditional | PDF ↗ |
| K133357 | CHARRUAPACS SYSTEM | Charruasoft SA | 2013-11-25 | Traditional | PDF ↗ |
| K132799 | CLARISO PACS | Clariso, Inc. | 2013-11-07 | Traditional | PDF ↗ |
| K132586 | PAXERAPACS | Paxeramed | 2013-10-31 | Traditional | PDF ↗ |
| K132316 | MULTIVIEW | Hologic, Inc. | 2013-10-30 | Traditional | PDF ↗ |
| K132188 | MAMMOGRAPHY VIEWER SMV658 | Fujifilm Medical System U.S.A., Inc. | 2013-10-25 | Traditional | PDF ↗ |
| K132636 | DYONICS PLAN HIP IMPINGEMENT PLANNING SYSTEM | Smith & Nephew, Inc. | 2013-10-17 | Traditional | PDF ↗ |
| K121447 | ISCHEMA VIEW RAPID | Ischemaview, Inc. | 2013-10-04 | Traditional | PDF ↗ |
| K122536 | AMCAD-UT DETECTION MODEL 2.0 | Lin & Associates, LLC | 2013-10-03 | Traditional | PDF ↗ |
| K131873 | NDOHD HIGH DEFINITION IMAGING SYSTEM (NDOHD) | MethodSense, Inc. | 2013-09-25 | Traditional | PDF ↗ |
| K131685 | GE ECHOPAC | Ge Vingmed Ultrasound AS | 2013-09-24 | Traditional | PDF ↗ |
| K131977 | CENTRICITY UNIVERSAL VIEWER ZERO FOOTPRINT CLIENT | GE Healthcare | 2013-09-17 | Traditional | PDF ↗ |
| K132302 | QXLINK | Vieworks Co., Ltd. | 2013-09-12 | Traditional | PDF ↗ |
| K131389 | JUSHA-C31 MEDICAL DISPLAY | Nanjing Jusha Display Technology Co., Ltd. | 2013-09-06 | Traditional | PDF ↗ |
| K123944 | KOSTEC MEDICAL GRADE LDC MONITORS | Kostec Co., Ltd. | 2013-09-05 | Traditional | PDF ↗ |
| K132610 | 5MP GRAYSCALE LCD DISPLAY | Shenzhen Beacon Display Technology Co., Ltd. | 2013-09-04 | Traditional | PDF ↗ |
| K131616 | EZ3D-I, E3 | Ewoosoft Co., Ltd. | 2013-08-29 | Traditional | PDF ↗ |
| K130374 | OMNI-VUE 2 SYSTEM | Genesis Digital Imaging, Inc. | 2013-08-29 | Special | PDF ↗ |
| K131594 | EZDENTI-I; E2; PRORA VIEW | Ewoosoft Co., Ltd. | 2013-08-29 | Traditional | PDF ↗ |
| K130242 | MAVEN PRO | Nsequence | 2013-08-29 | Traditional | PDF ↗ |
| K132587 | MD242C2 24 DIAGNOSTIC IMAGING LCD MONITOR | Ned Display Solutions , Ltd. | 2013-08-29 | Traditional | PDF ↗ |
| K131158 | CORVIEW | Marrek, Inc. | 2013-08-21 | Traditional | PDF ↗ |
| K131391 | JUSHA-M32 MEDICAL DISPLAY | Nanjing Jusha Display Technology Co., Ltd. | 2013-08-21 | Traditional | PDF ↗ |
| K130749 | SYNGO.MR GENERAL; SYNGO.MR CARDIOLOGY; SYNGO.MR VASCULAR | Siemens Medical Solutions USA, Inc. | 2013-08-20 | Traditional | PDF ↗ |
| K131570 | ORTHOVISION | Ewoosoft Co., Ltd. | 2013-08-15 | Traditional | PDF ↗ |
| K130779 | LVIVO EF SYSTEM | Diacardio, Ltd. | 2013-08-15 | Traditional | PDF ↗ |
| K132165 | QLAB QUANTIFICATION SOFTWARE | Philips Ultrasound, Inc. | 2013-08-09 | Traditional | PDF ↗ |
| K130743 | THE KINEGRAPH VMA (VERTEBRAL MOTION ANALYZER) SOFTWARE VERSION 2.0; THE MOTION NORMALIZER PATIENT HANDLING AND DATA COLL | Ortho Kinematics, Inc. | 2013-08-06 | Traditional | PDF ↗ |
| K131448 | 3D PROSTATE SUITE 3DTRUS PROSTATE MAPPING, MRI/3DTRUS FUSION OPTION, SECOND LOOK 3DTRUS FUSION OPTION | Koelis | 2013-07-26 | Traditional | PDF ↗ |
Product code LLZ · Class II · Radiology. Data: openFDA.