(85 days)
No
The summary describes a teleradiology system for image transmission and review, with no mention of AI, ML, or advanced image processing features typically associated with AI/ML in medical imaging.
No.
The device is a teleradiology system for reviewing and transmitting X-ray images, which is an imaging and communication tool, not a device that directly treats or diagnoses a medical condition.
No
The device is described as a teleradiology system for reviewing and transmitting X-ray images, not for diagnosing conditions.
Unknown
The summary describes a teleradiology system for reviewing and transmitting X-ray images. While this functionality is often software-based, the summary does not explicitly state that the device is only software and does not include any hardware components. It could be a system that includes dedicated hardware for image processing or display.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the TRS 2000 system is for "teleradiology system/transmission and advance reviewing station X-ray images." This involves the transmission and review of medical images, which is a function related to medical imaging and diagnosis, but not in vitro testing.
- Device Description: The description reinforces its function as a "teleradiology system/transmission and advance reviewing station X-ray images."
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any other components typically associated with in vitro diagnostic testing.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information about a person's health status. The TRS 2000 system deals with the handling and review of medical images, which is a different category of medical device.
N/A
Intended Use / Indications for 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.
Product codes
Not Found
Device Description
The TRS 2000 system is a teleradiology system/transmission and advance reviewing station X-ray images.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray images
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Typical users are phycians and nurses at a radiology deparment.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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.
Key Metrics
Not Found
Predicate Device(s)
Philips PMS Easy Vision (K920950)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.2050 Medical image management and processing system.
(a)
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.(b)
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).
0
Image /page/0/Picture/1 description: The image shows the word "SECTRA" in bold, black letters on the top line. Below the word "SECTRA" is the text "K961983" in a handwritten-style font. The text "K961983" is smaller than the word "SECTRA" and is also in black.
Department of Health and Human Services Center for Devices and Radiological Health Office of Device Evaluation Pre-Market Notification Section
15 May 1996
SECTRA Doc. no: 3-96.534-2.0/da-fri PV
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 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 Philips PMS Easy Vision (K920950). This information and data is summarized as follows:
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- The Teleradiology system TRS is subject to and in compliance with the Federal Performance Standards, defined in 21 CFR, part 1000.
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- The TRS system has been and will be manufactured in accordance with the voluntary standards listed in the enclosed External Standards survey.
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- The TRS User's Guide contains comprehensive and extensive information on how to operate the system to ensure a safe and effective use.
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- 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.
- The submission contains the results of an hazard analysis.
signature
Torbior Krishar Approbation Officer SECTRA - Imtec AB Linköping, Sweden
A
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