← Product Code [LLZ](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LLZ) · K961983 # TRS 2000 TELERADIOLOGY SYSTEM (K961983) _Sectra-Imtec AB · LLZ · Aug 13, 1996 · Radiology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LLZ/K961983 ## Device Facts - **Applicant:** Sectra-Imtec AB - **Product Code:** [LLZ](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LLZ.md) - **Decision Date:** Aug 13, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 892.2050 - **Device Class:** Class 2 - **Review Panel:** Radiology - **Attributes:** Software as a Medical Device ## Intended Use The TRS 2000 system is a teleradiology system/transmission and advance reviewing station X-ray images. TRS 2000 is used for advanced reviewing and transmission over private or public telecommunications networks of radiological images. ## Device Story Teleradiology system for transmission and review of radiological X-ray images; operates over private or public telecommunications networks; used by physicians and nurses in radiology departments; facilitates remote clinical review of images; supports clinical decision-making by enabling off-site radiological assessment. ## Clinical Evidence No clinical trial data provided. Safety and effectiveness supported by independent clinical operational experience and comparison to predicate device. ## Technological Characteristics Teleradiology transmission and review station; operates via telecommunications networks; complies with 21 CFR part 1000; manufactured per voluntary standards; hazard analysis performed. ## Regulatory Identification A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements. ## Special Controls *Classification.* Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern). ## Predicate Devices - Philips PMS EasyVision ([K920950](/device/K920950.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} AUG 13 1996 SECTRA K961983 15 May 1996 Department of Health and Human Services Center for Devices and Radiological Health Office of Device Evaluation Pre-Market Notification Section SECTRA Doc. no: 3-96.534-2.0/da-fri ## 510(k) summary of safety and effectiveness information for the SECTRA Teleradiology System TRS 2000 This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990. The TRS 2000 system is a teleradiology system/transmission and advance reviewing station X-ray images. TRS 2000 is used for advanced reviewing and transmission over private or public telecommunications networks of radiological images. Typical users are phycians and nurses at a radiology department. The undersigned certifies that the 510(k) Pre-Market Notification for the above referenced product contains adequate information and data to enable CDRH to determine substantial equivalence to Philips PMS EasyVision (K920950). This information and data is summarized as follows: 1. The Teleradiology system TRS is subject to and in compliance with the Federal Performance Standards, defined in 21 CFR, part 1000. 2. The TRS system has been and will be manufactured in accordance with the voluntary standards listed in the enclosed External Standards survey. 3. The TRS User's Guide contains comprehensive and extensive information on how to operate the system to ensure a safe and effective use. 4. Close co-operation with radiologists from the specifications to test phases and substantial independent experience from clinical operation has shown the TRS system to be safe and effective. Past experience with substantially equivalent predicate devices has also shown our device to be safe and effective when used as directed in the User's Guide. 5. The submission contains the results of an hazard analysis. Torbjörn Kronander Approbation Officer SECTRA - Imtec AB Linköping, Sweden --- **Source:** [https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LLZ/K961983](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LLZ/K961983) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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