K963395 · Sectra-Imtec AB · LMB · Oct 25, 1996 · Radiology
Device Facts
Record ID
K963395
Device Name
IMAGESERVER 2000 PICTURE ARCHIVING SYSTEM
Applicant
Sectra-Imtec AB
Product Code
LMB · Radiology
Decision Date
Oct 25, 1996
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 892.2010
Device Class
Class 1
Attributes
Software 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.
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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.
Dan Fristedt
Quality Assurance Manager
SECTRA AB
Linköping, Sweden
Telephone: +46 13 23 52 00
