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• 07:20, 25 August 2020 Dirkjan talk contribs created page CFR 1020.32 Fluoroscopic equipment (h)(2) Fluoroscopic irradiation time, display, and signal after June 10 2006 (Created page with "''(2) For x-ray controls manufactured on or after June 10, 2006'' There shall be provided for each fluoroscopic tube: * (i) A display of the fluoroscopic irradiation time at...")
• 07:20, 25 August 2020 Dirkjan talk contribs created page CFR 1020.32 Fluoroscopic equipment (g) Source-skin distance (Created page with "''(g) Source-skin distance'' * (1) Means shall be provided to limit the source-skin distance to ** not less than 38 cm on ''stationary'' fluoroscopes and to ** not less than...")
• 07:20, 25 August 2020 Dirkjan talk contribs created page CFR 1020.32 Fluoroscopic equipment (d)(4) Exemptions (Created page with "''(4) Exemptions'' Fluoroscopic radiation therapy simulation systems are exempt from the requirements set forth in paragraph (d) of this section. Category:fda")
• 07:20, 25 August 2020 Dirkjan talk contribs created page CFR 1020.32 Fluoroscopic equipment (f) Indication of potential and current (Created page with "''(f) Indication of potential and current'' During fluoroscopy and cinefluorography, x-ray tube potential and current shall be continuously indicated. Deviation of x-ray tube...")
• 07:20, 25 August 2020 Dirkjan talk contribs created page CFR 1020.32 Fluoroscopic equipment (d)(3) Measuring compliance (Created page with "''(3) Measuring compliance'' Compliance with paragraph (d) of this section shall be determined as follows: * (i) If the source is below the x-ray table, the AKR shall be measu...")
• 07:20, 25 August 2020 Dirkjan talk contribs created page CFR 1020.32 Fluoroscopic equipment (d)(1) equipment manufactured before May 19, 1995 (Created page with "''(1) Fluoroscopic equipment manufactured '''before May 19, 1995''''' * (i) Equipment provided with automatic exposure rate control (AERC) shall not be operable at any combina...")
• 07:20, 25 August 2020 Dirkjan talk contribs created page CFR 1020.32 Fluoroscopic equipment (d)(2) equipment manufactured on or after May 19, 1995 (Created page with "''(d)(2) Fluoroscopic equipment manufactured '''on or after May 19, 1995''''' * (i) Shall be equipped with AERC if operable at any combination of tube potential and current th...")
• 07:20, 25 August 2020 Dirkjan talk contribs created page CFR 1020.32 Fluoroscopic equipment (b)(4) Circular image receptors (Created page with "''(4) Fluoroscopy and radiography using the fluoroscopic imaging assembly with inherently '''circular''' image receptors'' * (i) For fluoroscopic equipment manufactured '''''...")
• 07:20, 25 August 2020 Dirkjan talk contribs created page CFR 1020.32 Fluoroscopic equipment (c) Activation of tube (Created page with "''(c) Activation of tube'' X-ray production in the fluoroscopic mode shall be controlled by a device which requires continuous pressure by the operator for the entire time of...")
• 07:20, 25 August 2020 Dirkjan talk contribs created page CFR 1020.32 Fluoroscopic equipment (b)(5) Rectangular image receptors (Created page with "''5) Fluoroscopy and radiography using the fluoroscopic imaging assembly with inherently '''rectangular''' image receptors.'' For x-ray systems manufactured on or after June...")
• 07:20, 25 August 2020 Dirkjan talk contribs created page CFR 1020.32 Fluoroscopic equipment (b)(3) Non-image-intensified fluoroscopy (Created page with "''(3) Non-image-intensified fluoroscopy'' The x-ray field produced by non-image-intensified fluoroscopic equipment shall not extend beyond the entire visible area of the image...")
• 07:20, 25 August 2020 Dirkjan talk contribs created page CFR 1020.32 Fluoroscopic equipment (b)(6) Override capability (Created page with "''(6) Override capability'' If the fluoroscopic x-ray field size is adjusted automatically as the SID or image receptor size is changed, a capability may be provided f...")
• 07:20, 25 August 2020 Dirkjan talk contribs created page CFR 1020.32 Fluoroscopic equipment (b)(2) Further means for limitation (Created page with "''(2) Further means for limitation'' Means shall be provided to permit further limitation of the x-ray field to sizes smaller than the limits of paragraphs CFR 1020.32 Fluor...")
• 07:20, 25 August 2020 Dirkjan talk contribs created page CFR 1020.32 Fluoroscopic equipment (b)(1) Angulation (Created page with "''(1) Angulation'' For fluoroscopic equipment manufactured after February 25, 1978, when the angle between the image receptor and the beam axis of the x-ray beam is variable,...")
• 07:20, 25 August 2020 Dirkjan talk contribs created page CFR 1020.32 Fluoroscopic equipment (a)(2) Measuring compliance (Created page with "''(2) Measuring compliance'' The AKR shall be measured in accordance with paragraph (d) of this section. The AKR due to transmission through the primary barrier combin...")
• 07:20, 25 August 2020 Dirkjan talk contribs created page CFR 1020.32 Fluoroscopic equipment (a)(1) Limitation of useful beam (Created page with "''(1) Limitation of useful beam'' The fluoroscopic imaging assembly shall be provided with a primary protective barrier which intercepts the entire cross section of the useful...")
• 07:20, 25 August 2020 Dirkjan talk contribs created page CFR 1020.32 Fluoroscopic equipment (Created page with "The provisions of this section apply to equipment for fluoroscopic imaging or for recording images from the fluoroscopic image receptor, except computed tomography x-ray syste...")
• 07:20, 25 August 2020 Dirkjan talk contribs created page CFR 1020.32 Fluoroscopic equipment (a) Primary protective barrier (Created page with " Category:fda")
• 07:20, 25 August 2020 Dirkjan talk contribs created page Warning Letter (Created page with "A warning letter is an administrative action typically issued to firms with a Situation I condition identified on their FDA 483 observations. Warni...")
• 07:20, 25 August 2020 Dirkjan talk contribs created page Category:Regulation (Created page with "{{category}}")
• 07:20, 25 August 2020 Dirkjan talk contribs created page Category:Traceability (Created page with "{{category}}")
• 07:20, 25 August 2020 Dirkjan talk contribs created page Webinar Recording: FDA Design Traceability Requirements for Device Development » The Seapine View (Created page with "=URL= http://blogs.seapine.com/2011/07/webinar-recording-fda-design-traceability-requirements-for-device-development/?utm_source=YouTube&utm_medium=SocialMedia&utm_campaign=So...")
• 07:20, 25 August 2020 Dirkjan talk contribs created page Verification (Created page with "In FDA Design Controls '''''Verification''''' means confirmation by examination and provision of objective evidence that specified requirem...")
• 07:20, 25 August 2020 Dirkjan talk contribs created page Verification Test Plan (Created page with "Verification test plans are created following the master test plan to ensure that each new or modified device is appriopiate for its intended use and approved prior to impleme...")
• 07:20, 25 August 2020 Dirkjan talk contribs created page Track I Inspection (Created page with "A ''Track I Inspection'' is a limitted inspection of a manufacturrs quality system performed by the FDA every two years. Routine inspections generally include a review of the...")
• 07:20, 25 August 2020 Dirkjan talk contribs created page Track II Inspection (Created page with "A ''Track II Inspection'' is a complete audit of a manufacturers quality system performed by the FDA every four years. Category:fda")
• 07:20, 25 August 2020 Dirkjan talk contribs created page Top-Down Inspection (Created page with "A ''Top-Down Inspection'' is the FDA's latest inspection strategy in which inspectors are taught to evaluate the quality system and sampling quality system records. The "top-...")
• 07:20, 25 August 2020 Dirkjan talk contribs created page The Act (Created page with "The United States Federal Food, Drug, and Cosmetic Act (abbreviated as FFDCA, FDCA, or FD&C), is a set of laws passed by Congress in 1938 giving authority to the U.S. Food and...")
• 07:19, 25 August 2020 Dirkjan talk contribs created page Test Plan (Created page with "In FDA Design Controls the '''''Test Plan''''' is a step-by-step plan to be followed during the verification or validaton of a product or p...")
• 07:19, 25 August 2020 Dirkjan talk contribs created page Specification (Created page with "In FDA Design Controls the '''''Specification''''' means any requirement with with which a product, process, service, or o...")
• 07:19, 25 August 2020 Dirkjan talk contribs created page Table-Top Inspection (Created page with "A ''Table-Top Inspection'' is an inspection strategy of reviewing a firms written procedures and perhaps records from a fixed location, such as an office or table-top and not...")
• 07:19, 25 August 2020 Dirkjan talk contribs created page Software Verification (Created page with "Software verification provides objective evidence that the design outputs of a particular phase of the software development life cycle meet all of the specified requirements f...")
• 07:19, 25 August 2020 Dirkjan talk contribs created page Software Validation (Created page with "'''Software Validation''' is a part of the Design Validation for a finished device, but is not separately defined in the Quality System regulation. For p...")
• 07:19, 25 August 2020 Dirkjan talk contribs created page Situation I (Created page with "In FDA Inspections Situation I conditions are those conditions that provide evidence that there are significant errors in the manufacturers production proc...")
• 07:19, 25 August 2020 Dirkjan talk contribs created page Risk Analysis (Created page with "In FDA Design Controls '''''Risk Analysis''''' is the ongoing investigation of the available inormation to identify hazards and estimate t...")
• 07:19, 25 August 2020 Dirkjan talk contribs created page SSRMM (Created page with "Sub System Risk Management Matrix Category:fda Category:Term")
• 07:19, 25 August 2020 Dirkjan talk contribs created page Requirements (Created page with "In FDA Design Controls the '''''Master Verification''''' are documented functions, conditions, or capabilities that a medical device must m...")
• 07:19, 25 August 2020 Dirkjan talk contribs created page Category:QSIT (Created page with "{{category}}")
• 07:19, 25 August 2020 Dirkjan talk contribs created page Quality System Inspection Technique (Created page with "The Quality System Inspection Technique (QSIT) provides guidance to the FDA field staff on a new inspectional process that may be used to assess a medical device manufacturer'...")
• 07:19, 25 August 2020 Dirkjan talk contribs created page RMM (Created page with "Risk Management Matrix Category:fda Category:Term")
• 07:19, 25 August 2020 Dirkjan talk contribs created page Quality System (Created page with "A ''Quality System'' means the organizational structure, responsibilities, procedures, processes and resources for implementing quality management. Quality System includes al...")
• 07:19, 25 August 2020 Dirkjan talk contribs created page Quality Policy (Created page with "In the FDA's Quality System Requirements ''Quality Policy'' means the overall quality intentions and direction of an organization with respect to Quality by Mana...")
• 07:19, 25 August 2020 Dirkjan talk contribs created page Production Specifications (Created page with "'''Production specifications''' must ensure that manufactured devices are repeatedly and reliably produced within product and process capabilities. One normally associates the...")
• 07:19, 25 August 2020 Dirkjan talk contribs created page Quality (Created page with "In the FDA's Quality System Requirements ''Quality'' means the totality of features and characteristics tha bear on the ability of a device to satisfy fitness for use, includi...")
• 07:19, 25 August 2020 Dirkjan talk contribs created page Product Proposal (Created page with "The Design Control Activities start with the ''output'' of the concept phase as the Design Input, this output is sometimes called the Product Proposal|Produ...")
• 07:19, 25 August 2020 Dirkjan talk contribs created page Premarket notification (Created page with "Premarket notification or 510(k) is a process by which a submitter notifies the FDA at least 90 days prior to the submitters inroduction of any appropriate device (...")
• 07:19, 25 August 2020 Dirkjan talk contribs created page PMA (Created page with "PMA is an abreviation for Premarket approval and is required for Class II Medical Devices Category:fda [[Category:FDA]...")
• 07:19, 25 August 2020 Dirkjan talk contribs created page Premarket approval (Created page with "Premarket approval (PMA) is a process by which Class II Medical Devices are approved to enter into interstate commerce. Typically, a PMA r...")
• 07:19, 25 August 2020 Dirkjan talk contribs created page Mastering and Managing the FDA Maze (Created page with "<<formTiddler <missing '>>'>NewBookTemplate>> <html> <iframe src="http://rcm.amazon.com/e/cm?t=httptiddlyweb-20&o=1&p=8&l=as1&asins=0873894553&ref=tf_til&...")
• 07:19, 25 August 2020 Dirkjan talk contribs created page Medical Device Report (Created page with "In FDA Design Controls the '''''Medical Device Report''''' (MDR) means Medical Device Reporting. To be elaborated... Category:fda Ca...")

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