Medical Device Tracking Guidance for Industry And FDA Staff March 2025
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작성자 Marissa Hermans… 작성일 25-09-12 06:57 조회 24 댓글 0본문

FDA is issuing this guidance to announce that each the checklist of units subject to medical system tracking necessities, and the list of medical gadgets launched from monitoring necessities, have been updated. This updated steerage identifies all affected devices (these tracked and those released from monitoring) in table format. The desk contains two fields to describe every machine: (1) product code (procode) and (2) the standardized procode definition (product code - most well-liked term). These two descriptive fields are meant to offer readability about which units are tracked. The product code and iTagPro device most well-liked title are usually discovered within the approval or travel security tracker clearance letter issued by CDRH. FDA's steering paperwork, together with this steerage, iTagPro device don't establish legally enforceable duties. Instead, guidances describe the Agency's current considering on a subject and should be considered only as recommendations, until particular regulatory or iTagPro device statutory requirements are cited. Using the word ought to in Agency guidances implies that something is advised or really helpful, but not required.
The invention relates to a big-angle intelligent solar tracker, which includes a moving platform and a fixed platform, and a first branch chain I, a second department chain II, a 3rd branch chain III, and a fourth department chain are put in between the shifting platform and the fastened platform. IV, the primary branch I and the third branch III have the identical construction and are symmetrically organized, and the second branch II and the fourth branch IV have the same structure and are symmetrically arranged; the primary department I includes the primary connecting rod, and the first connecting rod The upper end of the rod is connected with the transferring platform by way of the ball pair, the decrease end of the primary connecting rod is connected with the first Hooke hinge, and the primary Hooke hinge is linked with the mounted platform via the first connecting block by the primary shifting pair; the second department chain II Including the second connecting rod, the higher end of the second connecting rod is connected with the transferring platform via the second Hooke hinge, the lower end of the second connecting rod is connected with the second connecting block via the rotating pair, and iTagPro support the second connecting block and the mounted platform are moved by way of the second Secondary connection.
The 4 branch chains of the current invention type an area parallel closed-loop structure with the moving platform and the fastened platform, which can notice two-dimensional translation and two-dimensional rotational movement in area. 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 field of parallel robots, and particularly pertains to a 4-degree-of-freedom single-platform large-rotation-angle clever solar tracker that can notice precise tracking in environments equivalent to positioning, iTagPro official 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 often composed of a dynamic platform, a static platform and iTagPro device several department chains between the two platforms. It has the advantages of high rigidity, quick pace and excessive precision. It's broadly used in industrial robots, movement simulators, parallel machine instruments and different fields. In recent times, foreign international locations have successively utilized some mechanism configurations to industrial manufacturing (corresponding to: delta mechanism), pet gps alternative whereas there are fewer domestic ones, and they're rarely utilized 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, attitude leveling, solar tracking, and parallel machine instruments, it is often vital to realize massive displacements, massive rotation angles, and iTagPro tracker motions within 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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