Who is the manufacturer of TRS 2000 TELERADIOLOGY SYSTEM?

Sectra-Imtec AB filed the 510(k) submission for TRS 2000 TELERADIOLOGY SYSTEM (K961983).

What is the FDA product code for TRS 2000 TELERADIOLOGY SYSTEM?

LLZ. It is classified under 21 CFR 892.2050 as a Class 2 device in the Radiology panel.

What is the regulatory pathway for TRS 2000 TELERADIOLOGY SYSTEM?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like TRS 2000 TELERADIOLOGY SYSTEM?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

TRS 2000 TELERADIOLOGY SYSTEM

K961983 · Sectra-Imtec AB · LLZ · Aug 13, 1996 · Radiology

Device Facts

Record ID	K961983
Device Name	TRS 2000 TELERADIOLOGY SYSTEM
Applicant	Sectra-Imtec AB
Product Code	LLZ · Radiology
Decision Date	Aug 13, 1996
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.2050
Device Class	Class 2
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.

Indications for Use

Indicated for physicians and nurses in radiology departments for the transmission and advanced review of radiological X-ray images over telecommunications networks.

Regulatory Classification

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)

Related Devices

K972925 — ACCESS RADIOLOGY (FRAMEWAVE) TELERADIOLOGY IMAGE ACQUISITION AND DISTRIBUTION SYSTEM WITH PICTURE AND ARCHIVING COMMUNIC · Access Radiology Corp. · Dec 5, 1997
K992426 — RAYPAX WEB CLINICAL SYSTEM · Samsung Sds Co., Ltd. · Oct 13, 1999
K032022 — DIGITAL IMAGER · Pyramid Medical, Inc. · Sep 2, 2003
K971368 — IDS4 IMAGE DISPLAY SYSTEM SERIES · O Tech, Inc. · Jun 26, 1997
K182431 — Konicaminolta DI-X1 · Konica Minolta, Inc. · Nov 26, 2018

Submission Summary (Full Text)

{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