Radiology
14,649 FDA 510(k) clearances · Medical specialty
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| Record | Firm | Date |
|---|---|---|
| AQUILION PREMIUM (K120546) | Toshiba Medical Systems Corporation, Japan | 2012-06-13 |
| MULTIARRAY KIT (K121249) | Paramed S.R.L. | 2012-06-12 |
| DISCOVERY CT750 HD (K120833) | Ge Medical Systems, LLC | 2012-06-12 |
| AGILITY (K121328) | Elekta , Ltd. | 2012-06-12 |
| AERODR STITCHING SYSTEM (K120752) | Konica Minolta Medical & Graphic, Inc. | 2012-06-08 |
| SIMUPLAN TREATMENT PLANNING SYSTEM (K120551) | Simuplan S.L. | 2012-06-08 |
| PAX-FLEX3D, PHT-7000 (K121412) | VATECH Co., Ltd. | 2012-06-08 |
| BELLYBOARD, SBRT ACCESSORIES (K121545) | Medtec Inc. Dba Civco Medical Solutions | 2012-06-08 |
| SCENIUM 2.0 (K121074) | Siemens Medical Solutions USA, Inc. | 2012-06-08 |
| VIEWFLEX XTRA ICE CATHETER (K121381) | St Jude Medical | 2012-06-07 |
| FLAT PANEL DETECTOR (K121444) | Canon, Inc. - Medical Equpment Group | 2012-06-07 |
| TITANIUM FLETCHER-STYLE APPLICATOR SET-DEFINED GEOMETRY (K120731) | Varian Medical Systems, Inc. | 2012-06-06 |
| CENTRICITY PACS-IW (K121387) | Ge Healthcare Integrated IT Solutions | 2012-06-05 |
| S-250 PROTON BEAM RADIATION THERAPY SYSTEM (K120676) | Mevion Medical Systems | 2012-06-04 |
| VANTAGE TITAN (K120638) | Toshibamedical Systems Corporation | 2012-06-01 |
| SYNAPSE 3D NODULE ANALYSIS (K120679) | Fujifilm Medical Systems U.S.A, Inc. | 2012-06-01 |
| SR SUITE 1.0 (K121345) | Halifax Biomedical, Inc. | 2012-06-01 |
| SPECTRUM V.0 (K121023) | Intrinsic Medical Imaging | 2012-05-31 |
| GUIDEMIA (K121466) | Guidemia Technologies, LLC | 2012-05-31 |
| SIMPLANT IMMEDIATE SMILE DENTAL CARE SYSTEM (K113739) | Materialise Dental NV | 2012-05-30 |
| SITE RITE PREVUE ULTRASOUND SYSTEM AND PINPOINT NEEDLE GUIDE (K120882) | Bard Access Systems, Inc. | 2012-05-30 |
| OPTOS ADVANCE (K113696) | Optos Plc. | 2012-05-25 |
| PAX-DUO3D PLUS, PCT-5000 (K121236) | VATECH Co., Ltd. | 2012-05-24 |
| LEKSELL GAMMA KNIFE PERFEXION (K120811) | Elekta Instrument AB | 2012-05-24 |
| MRI MULTI-CHANNEL OPTICAL COMMUNICATION (MOC) SYSTEM IMROC/IMROC IR WIRLESS OPTOACTIVE (K121239) | Optoacoustics, Ltd. | 2012-05-24 |
| VANTAGE TITAN 3T (K120487) | Toshibamedical Systems Corporation | 2012-05-23 |
| SOMATOM DEFINITION EDGE (K120579) | Siemens Medical Systems, Inc. | 2012-05-23 |
| MYLABSOGNO (K121384) | Esaote, S.p.A. | 2012-05-23 |
| SOMATOM PERSPECTIVE (K113287) | Siemens Medical Solutions USA, Inc. | 2012-05-23 |
| AERODR X70 (K121109) | Konica Minolta Medical & Graphic, Inc. | 2012-05-23 |
| UNIVERSAL DIGITAL INTERFACE (UDI) 1717 (K112527) | Meridian Medical Systems, LLC | 2012-05-22 |
| VIEWRAY SYSTEM (K111862) | Viewray, Incorporated | 2012-05-22 |
| MRI SYTEMS (K113281) | Shenzhen Anke High-Tech Co., Ltd. | 2012-05-17 |
| ACUSON S3000 DIAGNOSTIC ULTRASOUND SYSTEM (K121138) | Siemens Medical Solution | 2012-05-17 |
| QLAB WITH FHN AND VPQ PLUG-IN (K121223) | Philips Ultrasound, Inc. | 2012-05-15 |
| EZSENSOR P DIGITAL INTRAORAL SENSOR (K121132) | Humanray Co,Ltd | 2012-05-10 |
| SYNAPSE 3D BRAIN PERFUSION (K120637) | Fujifilm Medical System U.S.A., Inc. | 2012-05-08 |
| SOMATOM DEFINITION FLASH (K121072) | Siemens Medical Systems, Inc. | 2012-05-08 |
| IPLAN (IPLAN CRANIAL, IPLAN STEREOTAXY, IPLAN ENT, IPLAN CMF, IPLAN VIEW, IPLAN SPINE) (K113732) | Brainlab AG | 2012-05-07 |
| VIVIX-S (K120020) | Vieworks Co., Ltd. | 2012-05-04 |
| EMBRACE THERMOPLASTIC (K120335) | Bionix Development Corp. | 2012-05-03 |
| RADIAPAK BRACHYTHERAPY APPLICATOR BALLOON DEVICE (K120344) | Radiadyne, LLC (Specification Developer) | 2012-05-03 |
| ATAL-8 (K113812) | Atlaim | 2012-05-03 |
| GUIDESHOT OPTION, SCENARIA WHOLE-BODY X-RAY CT SYSTEM (K113341) | Hitachi Medical Systems America, Inc. | 2012-05-03 |
| ECHOSTAR SPICA 1.5T MR SYSTEM (K113511) | Alltech Medical Systems America, Inc. | 2012-05-02 |
| ECHELON OVAL MRI SYSTEM (K113145) | Hitachi Medical Systems America, Inc. | 2012-05-01 |
| SPEEDUP SOFTWARE OPTION (K120748) | Esaote, S.p.A. | 2012-05-01 |
| VOLUSON S6, VOLUSON S8 (K120741) | GE Healthcare | 2012-04-27 |
| ACCUDXA2 (K113616) | Lone Oak Medical Technologies, LLC | 2012-04-27 |
| SURGICASE CONNECT (K113599) | Materialise NV | 2012-04-27 |
| ENCORE 14 SOFTWARE RELEASE FOR THE GE LUNAR DXA BONE DENSITOMETERS (K113286) | Ge Medical Systems Lunar | 2012-04-27 |
| PLASTIC NEEDLE WITH MANDRIN 2.0 DIAMETER LENGTH 113MM (K120341) | Varian Medical Systems, Inc. | 2012-04-27 |
| FLAT PANEL DETECTOR (K111824) | Canon Inc. -Medical Equipment Group | 2012-04-23 |
| VISIA (K120207) | MeVis Medical Solutions AG | 2012-04-23 |
| 3.7 MP COLOR LCD MONITOR, RADIFORCE MX270W (K113240) | Eizo Nanao Corporation | 2012-04-20 |
| PRE-LOADED GOLD VISICOIL CK MARKER (K120859) | Radiomed Corporation | 2012-04-19 |
| NOVAC 11 (K112286) | New Radiant Technology S.P.A. | 2012-04-19 |
| PHILIPS MICRODOSE (K120255) | Philips Digital Mammography Sweden AB | 2012-04-19 |
| EZONO 3000 (K120234) | Life-Tech, Inc. | 2012-04-19 |
| M7/M7T DIAGNOSTIC ULTRASOUND SYSTEM (K121010) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2012-04-19 |
| 2MP MONOCHROME LCD MONITOR, RADIFORCE GX240 (K120407) | Eizo Nanao Corporation | 2012-04-19 |
| GE VIVID E9 DIAGNOSTIC ULTRASOUND IMAGING SYSTEM (K120201) | Ge Vingmed Ultrasound AS | 2012-04-19 |
| RESOLUTIONMD WEB (K120076) | Calgary Scientific, Inc. | 2012-04-19 |
| DC-T6 DIAGNOSTIC ULTRASOUND SYSTEM (K120699) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2012-04-19 |
| OLEA SPHERE (K120196) | Olea Medical | 2012-04-19 |
| INSTAPACS/INSTARISPACS (K120718) | Meddiff Technologies Pvt. , Ltd. | 2012-04-19 |
| OPTIMA NM/CT 640 (K121019) | GE Healthcare | 2012-04-19 |
| LIAC (K110840) | Sordina S.P.A. | 2012-04-17 |
| 3MENSIO WORKSTATION (K120367) | Pie Medical Imaging BV | 2012-04-17 |
| RADIOGRAPHIC X-RAY SYSTEM (K120034) | Orich Medical Equipment (Tianjin Co., Ltd. | 2012-04-17 |
| CT-GUIDE NEEDLE GUIDANCE SYSTEM (K120300) | Activiews, Ltd. | 2012-04-13 |
| CLEARVISION DR 7000F (K102327) | Jpi Healthcare Co, Ltd. | 2012-04-13 |
| SYNGO CT DYNAMIC ANGIO (K120331) | Siemens AG Medical Solutions | 2012-04-13 |
| INTRABEAM NEEDLE APPLICATOR (K110590) | Carl Zeiss Surgical GmbH | 2012-04-13 |
| 2D CARDIAC PERFORMANCE ANALYSIS MR 1.0 (K120135) | Tomtec Imaging Systems GmbH | 2012-04-13 |
| ZONARE ZS3 DIAGNOSTIC UNLTRASOUND SYSTEM (K120703) | Zonare Medical Systems, Inc. | 2012-04-13 |
| SYNGO.MR SPECTRO ENGINE, SYNGO.MR SPECTRO SVS, SYNGO.MR SPECTRO CSI, SYNGO.MR SPECTRO EXTENSION (K120315) | Siemens Medical Solutions USA, Inc. | 2012-04-13 |
| DRX-REVOLUTION MOBILE X-RAY SYSTEM (K120062) | Carestream Health, Inc. | 2012-04-13 |
| ALPHAPOINT IMAGING SOFTWARE (K120161) | Radlogics, Inc. | 2012-04-13 |
| PEDCAT (K113548) | Curvebeam, LLC | 2012-04-10 |
| AQUILION ONE (K113466) | Toshiba Medical Systems Coporation, Japan | 2012-04-10 |
| AQUILION CXL (K112989) | Toshiba America Medical Systems, In.C | 2012-04-10 |
| AEROSYNC FOR AERODR SYSTEM (K120477) | Konica Minolta Medical & Graphic, Inc. | 2012-04-09 |
| AQUILION PRIME (K120710) | Toshibamedical Systems Corporation | 2012-04-06 |
| RAYSTATION (K120387) | Raysearch Laboratories AB | 2012-04-06 |
| MULTI-MODALITY IMAGE FUSION (K120187) | Igt, LLC Dba Eigen | 2012-04-06 |
| EOS (K120721) | Eos Imaging | 2012-04-06 |
| THE DOME GX4MP COLOR NONITOR (K120709) | Nds Surgical Imaging | 2012-04-06 |
| INSIGHT - FD MINI C-ARM FLUOROSCOPIC IMAGING SYSTEM (K120388) | Hologic, Inc. | 2012-04-06 |
| OEC 9900 ELITE (K120613) | Ge Healthcare Surgery GE Oec Medical Systems, Inc. | 2012-04-06 |
| SYNAPSE 3D BASE TOOLS (K120361) | Fujifilm Medical Systems U.S.A, Inc. | 2012-04-06 |
| GE ECHOPAC (K120221) | GE Healthcare | 2012-03-30 |
| INFANT ARRAY (K113365) | Advanced Imaging Research Dba Sree Medical Systems | 2012-03-29 |
| TOSHIBA 1.5T QD HEAD COIL (K120627) | Quality Electrodynamics | 2012-03-29 |
| VISIA ONCOLOGY (K120484) | MeVis Medical Solutions AG | 2012-03-27 |
| BRIVO MR355 (K120778) | Ge Hangwei Medical Systems Co., Ltd. | 2012-03-27 |
| BLADDER SCANNER (K113304) | MEDA Co., Ltd. | 2012-03-23 |
| SYNGO RT INTERFACE (K120363) | Siemens Medical Solutions USA, Inc. | 2012-03-20 |
| E-CUBE 9 (K120060) | Alpinion Medical Systems Co., Ltd. | 2012-03-16 |
| CLICKFIT TRANSFER GUIDE TUBES NEEDLE CLICKFIT TRANSFER GUIDE TUBES CATHETER TRANSFER GUIDE TUBE SET VARISOURCE LUER TRAN (K113766) | Varian Medical Systems, Inc. | 2012-03-16 |
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Every clearance here is in the API, with alerts when new ones post.