510k

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    Mobile MIM Receives Second FDA 510(k) Clearance, Adds X-Ray And Radiation Oncology

    MIM Software Inc., a leading global provider of medical imaging software, announced today that Mobile MIM™ has received its second FDA 510(k) clearance for the release of its new version, Mobile MIM 3.0. Mobile MIM is now cleared for diagnostic X-ray and ultrasound viewing, as well as radiation...
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    Translational Sciences Corporation Receives FDA 510(k) Clearance For Commercializatio

    Translational Sciences Corporation (TSC) announced that it has received FDA 510(k) clearance for commercialization of its OncoTrac™ medical imaging software. OncoTrac™ is designed for efficient quantitative assessment of treatment response of metastatic tumors including breast, lung, colorectal...
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    MedShape Solutions Announces FDA 510(k) Clearance Of Innovative Ankle Fusion Device

    MedShape Solutions, Inc., the industry leader in innovative shape memory orthopedic devices, announced its new DynaNail™ Intramedullary Ankle Fusion Nail. Ankle fusion is performed to relieve pain in patients with severely degenerative ankle joints, to correct joint deformities or to revise...
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    Nephros Receives 510k Approval To Market Additional Ultrafiltration Products

    Nephros, Inc. (OTC Bulletin Board: NEPH), a medical device company developing and marketing filtration products for therapeutic applications, infection control, and water purification, announced that the Company has received 510k clearance from the U.S. Food and Drug Administration to market...
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    Tomophase OCTIS(TM) Receives FDA 510(K) Clearance To Market

    Tomophase Corporation, developer of the non-invasive Optical Coherence Tomography Imaging System (OCTIS™) and other devices, announced that it has received FDA 510(k) clearance to market OCTIS. Tomophase is a leader in the development of OCT brochoscopically-based imaging systems for...
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    Optovue Announces FDA 510(k) Clearance For IVue SD-OCT

    Optovue, a pioneer in fourier/spectral-domain optical coherence tomography (OCT), has announced that the new iVue compact SD-OCT has received FDA 510(k) clearance on April 29, 2010. "The iVue compact SD-OCT was officially launched outside the United States in January of this year, and we have...
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    Smith & Nephew Receives FDA 510k Clearance For A 30-year Knee

    As evidence of its drive to return knee pain sufferers to a lifetime of physical activity, Smith & Nephew ( SNN, LSE: SN) Orthopaedics Division announces the results of unprecedented testing on its VERILAST technology for knee replacement implants. After simulating 30 years of physical activity...
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    Carl Zeiss Meditec Receives 510(k) Class II Clearance For Humphrey Field Analyzer's G

    Carl Zeiss Meditec announced that the U.S. Food and Drug Administration (FDA) has granted a 510(k) Class II clearance for the Humphrey® Field Analyzer (HFA) II-i with Guided Progression Analysis™ (GPA) software. The world's most widely used automated perimeter is now the only perimeter with GPA...
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    FDA Provides 510k Clearance For BARRX Medical's HALO90 Ablation Catheter For The Trea

    BARRX Medical, Inc. announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its HALO90 Ablation Catheter for the treatment of Radiation Proctitis (RP) and Gastric Antral Vascular Ectasia (GAVE). Both conditions are diseases of the...
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    FDA Provides 510k Clearance For BARRX Medical's HALO90 Ablation Catheter For The Trea

    BARRX Medical, Inc. announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its HALO90 Ablation Catheter for the treatment of Radiation Proctitis (RP) and Gastric Antral Vascular Ectasia (GAVE). Both conditions are diseases of the...
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