(156 days)
Not Found
No
The description focuses on standard image processing, archiving, and communication functionalities typical of early digital imaging systems. There is no mention of AI, ML, or any related concepts like deep learning, neural networks, or algorithms that learn from data. The analysis features described (ventricular functions, coronary analysis) appear to be based on predefined calculations rather than learned patterns.
No
The device is described as an archiving and communication station for vascular images, with features like image processing and analysis. It does not perform any direct therapeutic action or treatment.
No
Explanation: The device is described as an archiving, processing, analysis, management, and communication station for vascular images. While it performs analysis, its primary function is to manage and communicate existing images rather than to generate a medical diagnosis or provide a definitive interpretation of patient conditions. Its intended use focuses on handling and displaying image data obtained from other sources.
No
The device description explicitly states it is comprised of two principle assemblies: the Electronic Cabinet and the User Console, and mentions hardware components like laser video discs, internal hard disks, and connections to power sources and video signals.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "Vascular image archiving, processing, analysis, management and communication." This clearly focuses on handling and analyzing medical images, not on testing samples taken from the human body (like blood, urine, tissue, etc.) to diagnose a condition.
- Device Description: The description details how the device acquires, processes, archives, and communicates vascular images from angiographic systems. It talks about video signals, laser video discs, hard disks, and network communication. There is no mention of handling biological samples or performing tests on them.
- Input: The input is "Video signals from angiographic systems," which are image data, not biological samples.
- Anatomical Site: The anatomical site is "Vascular," referring to the blood vessels being imaged, not a sample taken from the body.
- Lack of IVD Characteristics: The description lacks any of the typical characteristics of an IVD, such as:
- Reagents or assays
- Sample handling procedures
- Measurement of biological markers
- Calibration with reference materials
In summary, the device is designed for managing and analyzing medical images of the vascular system, which falls under the category of medical imaging devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
Vascular image archiving, processing, analysis, management and communication.
Product codes (comma separated list FDA assigned to the subject device)
90 IZI
Device Description
The VIEW Archiving Station represents the first generation of Electromed International's vascular image archiving and communication stations. The VIEW Archiving Station is intended for vascular image archiving, processing, analysis, management, and communication as the Cinenet Cardiac Image Network with the exception of analysis which is available as an option with the Cardiac Image Management System (CIMS). Some of the features offered in the VIEW Archiving Station are: vascular image processing (zoom, panning, edge enhancement, contrast), analysis (left and right ventricular functions, quantitative coronary analysis), and communication (printing of reports and sending of exam information in DICOM or Electromed encapsulation over a local area network, including images). Images are acquired in real-time on both products.
The VIEW Archiving Station may be interfaced directly with the majority of image digitizers available in todays angiographic systems. It may be linked to video signals of 1249 lines at 25 images/sec or even 1049 lines at 30 images/sec. The video signal is then re-sampled in real time to yield a signal of 625 lines which then may be recorded on a laser video disc by the CRV.
The View Archiving Station is comprised of two principle assemblies: the Electronic Cabinet; and the User Console which is connected solely to the Electronic Cabinet. Unlike the Cinenet Cardiac Image Network which uses digital videocassettes as the archiving media, the VIEW Archiving Station archives it's images on laser video discs and the exam information on internal hard disks. Each uniquely numbered laser video disc holds approximately 48 minutes (24 per side) of recording time, 35-45 examinations. The internal hard disks encompasses records that contain patient and exam information along with the referenced video laser disk ID number, which in turn, contains the recorded images. Approximately 100,000 records can be maintained on the internal hard disks at the present time. The Cinenet Cardiac Image Network incorporates a Data Storage Library which contains anywhere from 84 to 1008 digital video cassettes for automatic retrieval, whereas the VIEW Archiving Station acts as a stand alone unit whereby the laser video discs are manually inserted when prompted.
The VIEW Archiving Station is to be connected to a 230V (±10%), 50/60Hz, 10A power source.
The configurable and add-on options being offered with the VIEW Archiving Station are: Room Loop Playback (the viewing of inages on a remote monitor in the orocedure room). Table Side Joystick (remote console in the procedure room to control the playback of recorded images); SVHS Copier (the recording of exams onto a SVHS tape); and a High Definition Printing of reports, including reference images at 1200cpi and 256 gray scale levels, via an ethernet local area network).
Since the VIEW Archiving Station can transmit information and images in a Dicom compliant format, via an ethernet local area network, a CD-R Station may be connected to record exams onto a transportable media (CD). The CD-R Station is not part of this 510(k) submission.
Since the options or combination of options, as stated above, are available as an integral part of the VIEW Archiving Station, the device will inevitably be offered in various configurations while maintaining the intended use and technological characteristics presented here within.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
video signals
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
Not Found
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).
Not Found
§ 892.1600 Angiographic x-ray system.
(a)
Identification. An angiographic x-ray system is a device intended for radiologic visualization of the heart, blood vessels, or lymphatic system during or after injection of a contrast medium. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image is a black and white logo. The logo is a circle with a geometric design inside. The design includes a horizontal line at the top, a trapezoid shape, and a series of horizontal lines at the bottom.
ELECTROMED INTERNATIONAL
2140 boul. industriel, St-Eustache (Quebec) Canada J7R 6R4
ustriel, St-Eustache (Quebec) Canada J7R SR4
01-2100 Fax: (514) 491-4138
Image /page/0/Picture/3 description: The image shows a logo or emblem with the words "Certified ISO 9001 Certified" stacked on top of each other. The text is in a bold, slightly distorted font, giving it a hand-drawn or stamped appearance. The word "Certified" appears twice, once at the top and once at the bottom, framing the "ISO 9001" text in the middle.
971176
510(k) NOTIFICATION (VIEW ARCHIVING STATION)
Page. 1
Sept. 3, 1997
February 17, 1997
(510(k) SUMMARY) APPENDIX B
510(k) SUMMARY
SUBMITTER: Electromed International 310 Industrial Blvd. St. Eustache, Quebec Canada J7R 5R4 Tel .: (514)-491-2100 Fax. (514)-491-4138
PREPARED BY: James Riedl
ﺘﻬ
Picture Archiving and Communication System, CFR 892.2050 (CLASS II) CLASSIFICATION NAME:
COMMON OR USUAL NAME: Vascular image archiving, and communications station
| PROPRIETARY NAME: | VIEW ARCHIVING STATION
( Vascular Integrated Electromed Workstation ) |
|-------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------|
| PREVIOUSLY MARKETED DEVICE TO
WHICH SUBSTANTIAL EQUIVALENCE
IS BEING CLAIMED: | Sony Medical System's
"Cinenet Cardiac Image Network" (K924708)
and Diagnostic Archive's "Cardiac Image Management
System (CIMS)" (K925961) |
The VIEW Archiving Station represents the first generation of Electromed International's vascular image archiving and communication stations. The VIEW Archiving Station is intended for vascular image archiving, processing, analysis, management, and communication as the Cinenet Cardiac Image Network with the exception of analysis which is available as an option with the Cardiac Image Management System (CIMS). Some of the features offered in the VIEW Archiving Station are: vascular image processing (zoom, panning, edge enhancement, contrast), analysis (left and right ventricular functions, quantitative coronary analysis), and communication (printing of reports and sending of exam information in DICOM or Electromed encapsulation over a local area network, including images). Images are acquired in real-time on both products.
The VIEW Archiving Station may be interfaced directly with the majority of image digitizers available in todays angiographic systems. It may be linked to video signals of 1249 lines at 25 images/sec or even 1049 lines at 30 images/sec. The video signal is then re-sampled in real time to yield a signal of 625 lines which then may be recorded on a laser video disc by the CRV.
The View Archiving Station is comprised of two principle assemblies: the Electronic Cabinet; and the User Console which is connected solely to the Electronic Cabinet. Unlike the Cinenet Cardiac Image Network which uses digital videocassettes as the archiving media, the VIEW Archiving Station archives it's images on laser video discs and the exam information on internal hard disks. Each uniquely numbered laser video disc holds
66
1
Image /page/1/Picture/0 description: The image is a black and white logo. The logo is a circle with a design inside. The design appears to be a stylized bridge or structure with a horizontal line above it. The structure has a trapezoidal shape with a series of horizontal lines at the bottom.
-Certified
ISO 9001
Certified
510(k) NOTIFICATION (VIEW ARCHIVING STATION)
Page: 2
APPENDIX B (510(k) SUMMARY)
approximately 48 minutes (24 per side) of recording time, 35-45 examinations. The internal hard disks encompasses records that contain patient and exam information along with the referenced video laser disk ID number, which in turn, contains the recorded images. Approximately 100,000 records can be maintained on the internal hard disks at the present time. The Cinenet Cardiac Image Network incorporates a Data Storage Library which contains anywhere from 84 to 1008 digital video cassettes for automatic retrieval, whereas the VIEW Archiving Station acts as a stand alone unit whereby the laser video discs are manually inserted when prompted.
The VIEW Archiving Station is to be connected to a 230V (±10%), 50/60Hz, 10A power source.
The configurable and add-on options being offered with the VIEW Archiving Station are: Room Loop Playback (the viewing of inages on a remote monitor in the orocedure room). Table Side Joystick (remote console in the procedure room to control the playback of recorded images); SVHS Copier (the recording of exams onto a SVHS tape); and a High Definition Printing of reports, including reference images at 1200cpi and 256 gray scale levels, via an ethernet local area network).
Since the VIEW Archiving Station can transmit information and images in a Dicom compliant format, via an ethernet local area network, a CD-R Station may be connected to record exams onto a transportable media (CD). The CD-R Station is not part of this 510(k) submission.
Since the options or combination of options, as stated above, are available as an integral part of the VIEW Archiving Station, the device will inevitably be offered in various configurations while maintaining the intended use and technological characteristics presented here within.
The VIEW Archiving Station does not in any way raise new questions of safety or effectiveness, when used as labeled, in comparison to the predicate device.
2
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an abstract caduceus symbol, which is often associated with healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP - 3 1997
James Riedi Quality Director Electromed International 310 boul. Industriel St-Eustache (Quebec) Canada J7R 5R4
Re: K971176
View Archiving Station (Vascular Image Archiving and Communication Station) Dated: July 7, 1997 Received: July 9, 1997 Regulatory class: II 21 CFR 892.1600/Procode: 90 IZI
Dear Mr. Riedl:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (2) CFR Part 80) and additionally 809.10 for in yitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for question and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours.
h. Lillian Yiu, Ph.D.
Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Image /page/3/Picture/0 description: The image shows the logo for Electromed International. The logo includes a black circle with a white design inside, followed by the company name in bold letters. To the right of the company name is a certification logo, and below the logo is the text '510(k) NOTIFICATION (VIEW ARCHIVING STATION)' and 'Page: 1'.
(INTENDED USE) APPENDIX C
Device:
Picture archiving and communications system, 21 CFR 892.2050, (CLASS II)
Model:
Intended Use:
VIEW ARCHIVING STATION
Vascular image archiving, processing, analysis, management and communication.
Note: For further details, please refer to the VIEW ARCHIVING STATION User Manual
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