Websites using fda 510(k)上市前通告申請 as a keyword

For all your replacement battery needs BatteryZone is your source. Featuring American made replacement FDA 510(k) compliant medical batteries too!

Embedded Software Validation Solutions for Safety-Critical Certification to Standards: RTCA DO-178C / DO-278Aand EUROCAE ED-12B /ED-109), Medical (FDA/CDRH 510(k and PMA, ISO-14971, IEC 60601 / IEC 61508 / 62304, Industrial IEC 61508 and Transportation and Rail systems IEC 62679, EN-50128, IEC 61508, 49CFR236 Subpart H

GPC Medical is a reputed Orthopaedic Implants (US FDA 510(k) Approved) Company. We are exporter and manufacturers of orthopaedic implants, orthopaedic instruments, bone screws, bone plates, modular bipolar, orthopedic implants from India.

OTech provides training and consulting primarily in the area of Medical Imaging (PACS, DICOM, and HL7) and compliance (HIPAA, quality systems and regulatory requirments).

a network of experienced professionals providing affordable, on-time product approvals via safety & regulatory agencies in the U.S., Canada, Europe, &

GPC Medical - India's #1 orthopedic implants manufacturers & suppliers. First & only Indian orthopaedics company having widest range of US FDA 510(k) approved orthopedic implants including bone plates, bone screws, interlocking nails, locking plate system, spinal implants, knee prosthesis, hip replacement implants & many more. Browse our orthopedic implants catalogue online and request for a FREE quote now!

FDA申請代行、510(k)コンサルティング、米国市場調査・米国進出のお手伝い、経営・販売戦略など、ロサンゼルスより日本人スタッフが対応。結果にこだわり他に類のない高いレベルのサービスを提供致します。

FDA 510(k)認證輔導, 教育訓練, 醫療器材客戶產品行銷美國的夥伴, 安全性及有效試驗測試設計執行

Conseil logiciel dispositifs médicaux, marquage CE et FDA 510(k), IEC 62304

FDA 510(k) consulting for medical device submission and CDRH clearance. Learn about the FDA approval and the pre-market notification 510(k) submission process.

Welcome to LifeLine Software Inc. featuring - RadCalc®. At LifeLine Software Inc., our vision is to create the highest quality software products that exceed our customers' expectations. We are striving to achieve this vision by our commitment and dedication to continuous improvement of all we do in responding to the needs of our customers Conventional and IMRT QA is now Fast, Easy & Accurate! RadCalc offers you the first and most powerful QA software program FDA 510(k) cleared to perform independent Monitor Unit validation calculations much faster and easier, by including fully automated dosimetric calculations, comprehensive institution and physics data setup, import (radiation therapy planning) and export (verify and record) features, powerful reporting tools, flexible site licensing, IMRT support, CyberKnife, Modulated Arc Therapy, Compensator based IMRT, Elekta, Varian & Siemens machine support, and many other features. We believe these advanced features can provide you with the most comprehensive automated MU validation system available today. Each software package includes setup, installation, training, and hardcopy printouts for billing and patient documentation. Windows XP, Vista, or 7 compatible. RadCalc was the first software to offer independent IMRT verification by adding an IMRT utility module in May of 2001. Since that time, RadCalc has become the number one selling software of its kind. We believe are success is driven by our commitment to provide the most fully automated and complete verification software as well as the finest customer and technical support possible. RadCalc® is now utilized in over 1500 cancer treatment centers worldwide and continues to grow rapidly as more and more centers are implementing IMRT technology. RadCalc® has become the market leader in independent MU & point dose verification by offering the most complete verification software package available today. Only RadCalc offers fully automated verification by utilizing add on RTP Import and V&R export utilities. RadCalc allows users to import treatment plan parameters directly from RTP systems or export directly to Verify and Record systems thus reducing or eliminating hand entry data errors. For a brief description on the different utilities, please see the product descriptions provided below. For more detailed information on RadCalc's features, please click on the available links that describe the benefits of utilizing these utilities. RadCalc Program and Available Modules RADCALC BASE PROGRAM: RadCalc® base software program is FDA 510(k) cleared to perform independent MU or point dose verification calculations for Conventional treatment plans including Electron, Photon, MLC, 3D Off Axis, Diode, and Enhanced Dynamic Wedge support. Software package includes a CD ROM disk, setup, installation, training, and hardcopy printouts for billing and patient documentation. Fully automated calculations for Conventional and IMRT plans are available by purchasing the RTP Import, V&R Export, and IMRT utilities separately. Windows XP, Vista, or 7 compatible. RTP IMPORT MODULE: The Import module provides the importing of treatment field parameters from a Radiation Therapy Planning system, Verify and Record system, and/or virtual simulation software. The interface transfers beam name, gantry angle, collimator angle, couch angle, field size, treatment depth, SSD, treatment dose, wedge information, blocked field area, compensator factors, block outlines, either static or dynamic MLC leaf sequences, coordinates of isocenter & calculation point, and the prescription information. RadCalc reads the above information and then performs the calculation. V AND R EXPORT MODULE: The V&R Export module provides the exporting of treatment field parameters and Monitor Units in a format that is readable by a Verify and Record system and/or Treatment Planning System. Parameters transferred include beam name, gantry angle, collimator angle, couch angle, field size, treatment depth, SSD, treatment dose, wedge information, either static or dynamic MLC leaf sequences, and the prescription information. Client must have RTP: Link, Exchange, or Connect from appropriate V&R vendor available. IMRT VALIDATION MODULE: The IMRT Validation module provides the verification of MU or point dose calculations for IMRT based treatment plans. The IMRT utility allows you to import from your treatment planning system either static or dynamic MLC leaf sequences. A modified Clarkson integration algorithm in RadCalc utilizes the MLC leaf sequences in order to compute the dose or MU. RadCalc is capable of handling an MLC with up to 200 leaves. The MLC leaf patterns are viewable within RadCalc's MLC Data tab. BRACHYTHERAPY MODULE: For HDR, HDR (Xoft), LDR, and Permanent Implant calculations. This module makes use of the TG-43 formalism. ROI MODULE: This module is used to import regions of interest for the calculation of depths and equivalent paths. It can be used for any type of calculation but its primary use is to obtain a more accurate result for VMAT verification calculations.

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