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 11 of 23
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K131498 | IQQA-LIVER MULTIMODALITY SOFTWARE | Edda Technology, Inc. | 2013-07-25 | Traditional | PDF ↗ |
| K131822 | ULTRAEXTEND USWS-900A V2.1 AND V3.1 | Toshiba America Medical Systems, In.C | 2013-07-23 | Traditional | PDF ↗ |
| K132062 | ESIE APPS SUITE | Siemens Medical Solutions USA, Inc. | 2013-07-23 | Traditional | PDF ↗ |
| K131137 | 21.3 INCH MONOCHROME DIGITAL MAMMOGRAPHY LCD MONITOR MS55I2 (ML21055, MD211G5) | Jvckenwood Corporation | 2013-07-18 | Traditional | PDF ↗ |
| K131424 | MIPLATFORM MEDICAL IMAGING SUITE | Hinacom Software and Technology, Ltd. | 2013-07-12 | Traditional | PDF ↗ |
| K131090 | 2MP COLOR LCD MONITOR, RADIFORCE MX215 | Eizo Corporation | 2013-07-03 | Traditional | PDF ↗ |
| K130724 | CODIAGNOSTIX IMPLANT PLANNING SOFTWARE | Straumann USA | 2013-06-28 | Traditional | PDF ↗ |
| K130542 | SYNAPSE 3D LUNG AND ABDOMEN ANALYSIS | Fujifilm Medical System U.S.A., Inc. | 2013-06-14 | Traditional | PDF ↗ |
| K130278 | MR PERMEABILITY | Philips Medical Systems Nederland B.V. | 2013-05-29 | Traditional | PDF ↗ |
| K131392 | ETIAM PACS COMPONENTS | Etiam S.A.S.U. | 2013-05-29 | Traditional | PDF ↗ |
| K131295 | NIO COLOR 3MP LED | Barco N.V. | 2013-05-29 | Special | PDF ↗ |
| K131246 | CORONIS 3MP | Barco N.V. | 2013-05-24 | Special | PDF ↗ |
| K131299 | ANYTHINK PACS WORKSTATION | Beijing Crealife Technology Co., Ltd. | 2013-05-22 | Traditional | PDF ↗ |
| K123306 | NORDIC TUMOREX | Nordicneurolab | 2013-05-20 | Traditional | PDF ↗ |
| K124051 | THE VAULT SYSTEM | Somersault Orthopedics, Inc. | 2013-05-17 | Traditional | PDF ↗ |
| K123082 | MOBILECT VIEWER | Nephosity, Inc. | 2013-05-16 | Traditional | PDF ↗ |
| K131118 | 4D VIEW | GE Healthcare | 2013-05-16 | Special | PDF ↗ |
| K130159 | QLAB QUANTIFICATION SOFTWARE HEART MODEL | Philips Health Care | 2013-05-13 | Traditional | PDF ↗ |
| K130624 | CONI | Globalmed | 2013-05-07 | Traditional | PDF ↗ |
| K130770 | MD211C3 21.3 DIAGNOSTIC IMAGING LCD MONITOR | Nec Display Solutions , Ltd. | 2013-04-18 | Traditional | PDF ↗ |
| K130772 | MD211C2 21.3 DIAGNOSTIC IMAGING LCD MONITOR | Nec Display Solutions , Ltd. | 2013-04-18 | Traditional | PDF ↗ |
| K130929 | ZMED VP4000 | Zmed, Inc. | 2013-04-12 | Traditional | PDF ↗ |
| K130884 | XELERIS 3.1 PROCESSING AND REVIEW WORKSTATION | Ge Medical Systems F.I. Haifa | 2013-04-12 | Traditional | PDF ↗ |
| K130383 | SYNAPSE 3D CARDIAC TOOLS | Fujifilm Medical System U.S.A., Inc. | 2013-04-09 | Traditional | PDF ↗ |
| K130069 | INNOVA EPVISION 2.0, INNOVA EPVISION 2.0 | GE Healthcare | 2013-04-05 | Traditional | PDF ↗ |
| K121916 | INTUITION | Terarecon,Inc. | 2013-04-02 | Traditional | PDF ↗ |
| K130336 | 5MP MONOCHROME LCD MONITOR, RADIFORCE GX540 | Eizo Nanao Corporation | 2013-03-28 | Traditional | PDF ↗ |
| K123976 | NOBELCLINICIAN | Nobel Biocare AB | 2013-03-26 | Traditional | PDF ↗ |
| K130393 | MIRADA RTX | Mirada Medical, Ltd. | 2013-03-20 | Traditional | PDF ↗ |
| K130228 | SUITEHEART | Neosoft, LLC | 2013-03-20 | Traditional | PDF ↗ |
| K123186 | RESOLUTIONMD MOBILE 3.1 MODEL RMD-MOB-31 | Calgary Scientific, Inc. | 2013-03-14 | Traditional | PDF ↗ |
| K130395 | STEREOS WORKSTATION | Eos Imaging, Inc. | 2013-03-11 | Special | PDF ↗ |
| K123426 | MEDICVOD, MEDICAST, MEDISHOW, MEDISEARCH, CENTRAL STORAGE SYSTEM - CSS | Orpheus Medical , Ltd. | 2013-03-01 | Traditional | PDF ↗ |
| K122578 | VITREA CT TRANSCATHETER AORTIC VALVE REPLACMENT (TAVR) PLANNING | Vital Images, Inc. | 2013-02-25 | Traditional | PDF ↗ |
| K123650 | ARIX RAD ACQUISITION CONSOLE | Compania Mexicana DE Radiologia Cgr, S.A. DE C.V. | 2013-02-20 | Traditional | PDF ↗ |
| K123575 | MAMMOWORKSTATION | Image Diagnost International GmbH | 2013-02-19 | Traditional | PDF ↗ |
| K120851 | COMMUNIFY PACS VIEWER | Communify Health, LLC | 2013-02-19 | Traditional | PDF ↗ |
| K130103 | CORONIS FUSION 6MP | Barco N.V. | 2013-02-08 | Special | PDF ↗ |
| K123023 | SURGERY REHEARSAL PLATFORM | Surgical Theater, LLC | 2013-02-08 | Traditional | PDF ↗ |
| K130070 | 4MP COLOR LCD MONITOR, RADIFORCE RX440 | Eizo Nanao Corporation | 2013-02-08 | Traditional | PDF ↗ |
| K123970 | CAAS INTRAVASCULAR | Pie Medical Imaging BV | 2013-02-06 | Traditional | PDF ↗ |
| K123420 | SYNGO, BREAST CARE | Siemens Medical Solutions USA, Inc. | 2013-02-01 | Traditional | PDF ↗ |
| K123519 | INVIVO DENTAL | Anatomage, Inc. | 2013-02-01 | Traditional | PDF ↗ |
| K124048 | IMAGEQUBE | Intuitive Imaging Informatics, LLC | 2013-01-29 | Traditional | PDF ↗ |
| K123269 | PROCEDURE REHEARSAL STUDIO | Simbionix , Ltd. | 2013-01-29 | Special | PDF ↗ |
| K123901 | TRACTUS TISSUEMAPPER REVIEWER APPLICATION | Tractus Corporation | 2013-01-29 | Traditional | PDF ↗ |
| K123894 | GE ECHOPAC | Ge Vingmed Ultrasound AS | 2013-01-29 | Traditional | PDF ↗ |
| K123577 | SYNGO.VIA MI WORKFLOWS | Siemens Medical Solutions USA, Inc. | 2013-01-22 | Special | PDF ↗ |
| K123566 | SYNAPSE 3D COLON ANALYSIS | Fujifilm Medical Systems U.S.A, Inc. | 2013-01-22 | Traditional | PDF ↗ |
| K123920 | SYNGO.VIA | Siemens AG Medical Solutions | 2013-01-18 | Traditional | PDF ↗ |
| K121762 | CARDIAC VX | Ge Medical Systems, LLC | 2013-01-18 | Traditional | PDF ↗ |
| K123922 | SYNGO DYNAMICS | Siemens Medical Solutions USA, Inc. | 2013-01-16 | Traditional | PDF ↗ |
| K123302 | IB CLINIC | Imaging Biometrics, LLC | 2013-01-11 | Traditional | PDF ↗ |
| K121296 | INTERVENTIONAL WORKSPOT | Philips Medical Systems Nederland B.V. | 2013-01-02 | Traditional | PDF ↗ |
| K123526 | CLEARREAD +CONFIRM | Riverain Technologies | 2012-12-27 | Traditional | PDF ↗ |
| K123530 | MAMMOGRAPHY PRIOR ENHANCEMENT (MPE) | Hologic, Inc. | 2012-12-20 | Traditional | PDF ↗ |
| K123528 | SCENIUM | Siemens Medical Solutions USA, Inc. | 2012-12-20 | Special | PDF ↗ |
| K120995 | ERAD PACS/ERAD RIS/PACS/ERAD EPVLITE VIEWER SOFTWARE PRODUCT | Erad, Inc. | 2012-12-03 | Traditional | PDF ↗ |
| K122429 | VESSEL ANALYSIS AND AUTOPLAQUE FOR ORS VISUAL | Object Research Systems (Ors), Inc. | 2012-11-28 | Traditional | PDF ↗ |
| K123375 | SYNGO.VIA | Siemens AG | 2012-11-20 | Traditional | PDF ↗ |
| K123174 | CENTRICITY PACS-IW WITH UNIVERSAL VIEWER | GE Healthcare | 2012-11-16 | Special | PDF ↗ |
| K113344 | STEREOS WORKSTATION | Eos Imaging | 2012-11-16 | Traditional | PDF ↗ |
| K121200 | FLIGHTPLAN FOR LIVER | GE Healthcare | 2012-11-02 | Traditional | PDF ↗ |
| K121213 | VITREAADVANCED | Vital Images, Inc. | 2012-11-02 | Traditional | PDF ↗ |
| K121781 | ECHONAVIGATOR RELEASE 1 | Philips Medical Systems Nederland B.V. | 2012-10-26 | Abbreviated | PDF ↗ |
| K122289 | IMAGE-COM 5.0 | Tomtec Imaging Systems GmbH | 2012-10-24 | Traditional | PDF ↗ |
| K122523 | CARESTREAM VUE PACS | Carestream Health, Inc. | 2012-10-23 | Traditional | PDF ↗ |
| K121076 | ULTRAEXTEND FX, ULTRASOUND WORKSTATION PACKAGE | Toshiba America Medical Systems, In.C | 2012-10-09 | Traditional | PDF ↗ |
| K122843 | MD211G3 21.3 DIAGNOSTIC IMAGING LCD MONITOR | Prodigy Technology Consultant Co., Ltd. | 2012-10-05 | Traditional | PDF ↗ |
| K122022 | ATHEROEDGE | Atheropoint, LLC | 2012-09-26 | Traditional | PDF ↗ |
| K111142 | ECHOSOFT(TM) | Echometrix, LLC | 2012-09-21 | Traditional | PDF ↗ |
| K120288 | ORTHOCAD SOFTWARE OPTION | Esaote, S.p.A. | 2012-09-19 | Traditional | PDF ↗ |
| K122260 | AYCAN MOBILE | Aycan Digitalsysteme GmbH | 2012-09-12 | Traditional | PDF ↗ |
| K122427 | CS ORTHODONTIC IMAGING SOFTWARE CS OMS IMAGING SOFTWARE | Carestream Dental, LLC | 2012-09-12 | Special | PDF ↗ |
| K122164 | MR VESSELLQ XPRESS | GE Medical Systems SCS | 2012-09-07 | Traditional | PDF ↗ |
| K122136 | VITREAVIEW | Vital Images, Inc. | 2012-09-07 | Traditional | PDF ↗ |
| K122329 | BIOJET | Jet Soft Srl | 2012-08-16 | Traditional | PDF ↗ |
| K122205 | EXINI | Exini Diagnostics AB | 2012-08-15 | Traditional | PDF ↗ |
| K120451 | 8MP COLOR LCD MONITOR, REDIFORCE RX840 | Eizo Nanao Corporation | 2012-08-03 | Traditional | PDF ↗ |
| K120734 | MICROSOFT AMALGA UIS IMAGE PROCESSING MODULE | Microsoft Corp. | 2012-08-02 | Traditional | PDF ↗ |
| K121292 | DYNAPBV BODY SOFTWARE | Siemens Medical Solutions USA, Inc. | 2012-07-30 | Traditional | PDF ↗ |
| K121075 | NERVEVISION SOFTWARE SYSTEMS | 3D Imaging Partners, Inc. | 2012-07-26 | Traditional | PDF ↗ |
| K121788 | NIO 5MP | Barco N.V. | 2012-07-23 | Traditional | PDF ↗ |
| K121517 | VERSAVUE ENTERPRISE SUITE | Icad, Inc. | 2012-07-20 | Special | PDF ↗ |
| K113562 | 3MP COLOR LCD MONITOR, RADIFORCE RX340 | Eizo Nanao Corporation | 2012-07-16 | Traditional | PDF ↗ |
| K113620 | MYRIAN 1.11 | Intrasense | 2012-07-12 | Traditional | PDF ↗ |
| K121449 | DIRECTPATH | Cybernet Systems Co., Ltd. | 2012-07-10 | Traditional | PDF ↗ |
| K120305 | THINKINGNET, THINKINGPACS/RIS - PROPRIETARY NAME FRO THINKINGNET, THINKINGARCHIVE (OR NUPAX) - THE MANAGEMENT AND ARCHIV | Thinking Systems Corp. | 2012-07-09 | Traditional | PDF ↗ |
| K120733 | SIMPLANT GO | Materialise Dental NV | 2012-07-05 | Traditional | PDF ↗ |
| K120636 | SYNAPSE 3D CARDIAC TOOLS | Fujifilm Medical System U.S.A., Inc. | 2012-07-05 | Traditional | PDF ↗ |
| K120514 | CARDIOPACS | Lumedx | 2012-07-05 | Abbreviated | PDF ↗ |
| K121459 | SYNGO.MR NEUROLOGY | Siemens Medical Solutions USA, Inc. | 2012-06-22 | Traditional | PDF ↗ |
| K120472 | QUANTRA | Hologic, Inc. | 2012-06-22 | Traditional | PDF ↗ |
| K113456 | READY VIEW | Ge Healthcare (Ge Medical Systems Scs) | 2012-06-15 | Special | PDF ↗ |
| K120648 | SYNAPSE 3D LUNG AND ABDOMEN ANALYSIS | Fujifilm Medical System U.S.A., Inc. | 2012-06-14 | Traditional | PDF ↗ |
| K121074 | SCENIUM 2.0 | Siemens Medical Solutions USA, Inc. | 2012-06-08 | Traditional | PDF ↗ |
| K121387 | CENTRICITY PACS-IW | Ge Healthcare Integrated IT Solutions | 2012-06-05 | Special | PDF ↗ |
| K120679 | SYNAPSE 3D NODULE ANALYSIS | Fujifilm Medical Systems U.S.A, Inc. | 2012-06-01 | Traditional | PDF ↗ |
| K121466 | GUIDEMIA | Guidemia Technologies, LLC | 2012-05-31 | Traditional | PDF ↗ |
| K121023 | SPECTRUM V.0 | Intrinsic Medical Imaging | 2012-05-31 | Traditional | PDF ↗ |
Product code LLZ · Class II · Radiology. Data: openFDA.