Medical Device Tracking Guidance for Industry And FDA Staff March 2025
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작성자 Clay 댓글 0건 조회 26회 작성일 25-09-18 11:21본문
FDA is issuing this steerage to announce that both the record of devices topic to medical machine tracking necessities, and the checklist of medical units released from tracking requirements, iTagPro device have been up to date. This up to date steerage identifies all affected units (these tracked and people launched from monitoring) in table format. The table includes two fields to describe every iTagPro device: ItagPro (1) product code (procode) and (2) the standardized procode definition (product code - most well-liked time period). These two descriptive fields are supposed to supply clarity about which units are tracked. The product code and preferred name are generally discovered in the approval or iTagPro device clearance letter issued by CDRH. FDA's steerage paperwork, together with this guidance, don't set up legally enforceable tasks. Instead, guidances describe the Agency's current pondering on a topic and should be considered only as suggestions, until specific regulatory or statutory requirements are cited. The use of the phrase should in Agency guidances means that something is instructed or recommended, but not required.
The invention pertains to a large-angle clever photo voltaic tracker, which features a moving platform and best bluetooth tracker a set platform, and a first department chain I, a second department chain II, a third department chain III, and a fourth branch chain are put in between the moving platform and the fixed platform. IV, the first branch I and the third branch III have the identical construction and are symmetrically organized, and the second branch II and the fourth department IV have the same structure and are symmetrically arranged; the first branch I consists of the primary connecting rod, and the primary connecting rod The upper finish of the rod is related with the shifting platform via the ball pair, the decrease finish of the primary connecting rod is related with the primary Hooke hinge, and itagpro device the primary Hooke hinge is linked with the mounted platform through the first connecting block by means of the first shifting pair; the second department chain II Including the second connecting rod, the upper finish of the second connecting rod is connected with the transferring platform via the second Hooke hinge, the decrease finish of the second connecting rod is linked with the second connecting block by way of the rotating pair, and iTagPro device the second connecting block and iTagPro smart tracker the mounted platform are moved by the second Secondary connection.
The four branch chains of the current invention kind a space parallel closed-loop construction with the shifting platform and the fixed platform, itagpro device which can realize two-dimensional translation and pet gps alternative two-dimensional rotational motion in house. 本发明属于并联机器人领域,特别涉及一种应用于定位、气象、雷达等环境下能够实现精确跟踪的四自由度单平台大转角智能太阳追踪器。 The invention belongs to the sphere of parallel robots, and in particular relates to a 4-degree-of-freedom single-platform massive-rotation-angle intelligent sun tracker that may realize precise monitoring in environments similar to positioning, meteorology, and radar. 并联机构通常由动平台、静平台及两平台之间的若干支链组成,具有刚度大、速度快、精度高的优点,在工业机器人、运动模拟器、并联机床等领域得到广泛应用。
近些年,国外已将陆续将部分机构构型应用于工业生产中(如:delta机构),而国内则较少,而且很少应用在生产生活中。 The parallel mechanism is usually composed of a dynamic platform, a static platform and several other department chains between the 2 platforms. It has the benefits of high rigidity, quick velocity and excessive precision. It is extensively utilized in industrial robots, movement simulators, parallel machine tools and other fields. In recent years, iTagPro device foreign countries have successively utilized some mechanism configurations to industrial production (resembling: delta mechanism), while there are fewer home ones, and they're rarely used in manufacturing and life. 在运动模拟器、姿态调平、太阳能追踪以及并联机床等领域,通常需要实现大位移、大转角,实现较大工作空间范围内的运动。
Within the fields of motion simulators, perspective leveling, solar monitoring, and parallel machine instruments, it's often mandatory to achieve massive displacements, giant rotation angles, and motions inside a big working house. 国内太阳能发电普遍采用固定式太阳能电池安装方式,尽管这种安装方式结构简单、成本较低,但是无法精确跟踪太阳位置,光能转换效率较低。 现有研究中,也存在部分运动型太阳能机构,单轴或双轴等多为串联机构精度不高。 其中双轴的跟踪精度相对较高,太阳板能达到的转换效率相对较大,但遇到恶劣天气难以保证装置的安全性。
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