(58 days)
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No
The summary describes a system for digital image storage and archival, with no mention of AI, ML, or any advanced image processing that would typically involve these technologies.
No
Explanation: The device is described as storing images for archival, which is an administrative function and not a therapeutic intervention.
No
The document states the device "will be used for digitally store images for archival together with informaton about the images," and does not mention any diagnostic function or processing of images.
Unknown
The summary describes a system for digitally storing images and information, which could be software. However, it doesn't explicitly state that the device is only software and provides no details about hardware components or lack thereof.
Based on the provided information, the ImageServer 2000 System is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The stated intended use is to "digitally store images for archival together with information about the images." This describes a system for managing and storing medical images, not a device used to examine specimens derived from the human body to provide information for diagnosis, monitoring, or compatibility testing.
- Device Description: The description reiterates the storage and archival function.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples, chemical reactions, or any other processes typically associated with IVD devices.
- Intended User/Care Setting: While used by medical professionals in a radiology department, this is consistent with a system for managing medical imaging data, not necessarily an IVD.
The function described is that of a medical image management and archival system, which falls under a different regulatory classification than IVDs.
N/A
Intended Use / Indications for Use
The ImageServer 2000 System will be used for digitally store images for archival together with informaton about the images.
Product codes (comma separated list FDA assigned to the subject device)
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Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
trained medical professionals at a radiology deparment.
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 892.2010 Medical image storage device.
(a)
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.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 892.9.
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Image /page/0/Picture/1 description: The image shows the word "SECTRA" in bold, black letters. The letters are large and blocky, and they appear to be slightly distressed or worn. The background is white, which makes the black letters stand out prominently. The overall impression is one of a strong, established brand or company.
Department of Health and Human Services Center for Devices and Radiological Health Office of Device Evaluation Pre-Market Notification Section
16 August 1996
K9633395
SECTRA Doc. no: 3-96.842-2.0/da-fri A
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 deparment.
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 Systms, Inc. (K922164). This information and data is summarized as follows:
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- The ImageServer system is subject to and in compliance with the Federal Performance Standards, defined in 21 CFR, part 1000.
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- The ImageServer system has been and will be manufactured in accordance with the voluntary standards listed in the enclosed voluntary standard survey.
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- The ImageServer User's Guide contains comprehensive information on how to operate the system to ensure a safe and effective use.
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- The submission contains the results of an hazard analysis.
signature
Dan Fristedt Quality Assurance Manager SECTRA AB Linköping, Sweden Telephone: +46 13 23 52 00
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