IMAGESERVER 2000 PICTURE ARCHIVING SYSTEM

K963395 · Sectra-Imtec AB · LMB · Oct 25, 1996 · Radiology

Device Facts

Record IDK963395
Device NameIMAGESERVER 2000 PICTURE ARCHIVING SYSTEM
ApplicantSectra-Imtec AB
Product CodeLMB · Radiology
Decision DateOct 25, 1996
DecisionSESE
Submission TypeTraditional
Regulation21 CFR 892.2010
Device ClassClass 1
AttributesSoftware as a Medical Device

Indications for Use

The ImageServer 2000 System will be used for digitally store images for archival together with informaton about the images. The typical users are trained medical professionals at a radiology department.

Device Story

ImageServer 2000; digital image archival system; stores medical images and associated metadata; used by trained medical professionals in radiology departments; facilitates management of radiological image data; ensures archival integrity; supports clinical workflow by providing access to stored image records.

Clinical Evidence

No clinical data; bench testing and hazard analysis provided.

Technological Characteristics

Digital image archival system; operates in compliance with 21 CFR Part 1000; manufactured per voluntary standards; software-based image management.

Indications for Use

Indicated for trained medical professionals in radiology departments for the digital storage and archival of medical images and associated information.

Regulatory Classification

Identification

A medical image storage device is a hardware device that provides electronic storage and retrieval functions for medical images. Examples include electronic hardware devices employing magnetic and optical discs, magnetic tapes, and digital memory.

Predicate Devices

Related Devices

Submission Summary (Full Text)

{0} OCT 25 1996 SECTRA 16 August 1996 K963395 Department of Health and Human Services Center for Devices and Radiological Health Office of Device Evaluation Pre-Market Notification Section SECTRA Doc. no: 3-96.842-2.0/da-fri **510(k) summary of safety and effectiveness information for the SECTRA ImageServer 2000 Picture Archiving System** This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990. The ImageServer 2000 System will be used for digitally store images for archival together with informaton about the images. The typical users are trained medical professionals 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 Olicon Imaging Systems, Inc. (K922164). This information and data is summarized as follows: 1. The ImageServer system is subject to and in compliance with the Federal Performance Standards, defined in 21 CFR, part 1000. 2. The ImageServer system has been and will be manufactured in accordance with the voluntary standards listed in the enclosed voluntary standard survey. 3. The ImageServer User's Guide contains comprehensive and extensive information on how to operate the system to ensure a safe and effective use. 4. The submission contains the results of an hazard analysis. ![img-0.jpeg](img-0.jpeg) Dan Fristedt Quality Assurance Manager SECTRA AB Linköping, Sweden Telephone: +46 13 23 52 00
Innolitics

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