(75 days)
No
The description focuses on basic data transfer and display functionalities for DICOM images, with no mention of advanced image analysis, pattern recognition, or learning algorithms.
No
The device is described as a CD writer and reader for DICOM images, used for viewing and transporting images, not for treating any medical condition.
No
The device is described as a CD writer and reader for DICOM images, used for engraving, viewing, and transporting images, not for interpreting or analyzing them to diagnose a condition.
No
The device description explicitly states it is comprised of two principal assemblies: a personal computer and a monitor, indicating it includes hardware components beyond just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is solely for the engraving, reading, and viewing of DICOM compliant images. This involves handling and displaying medical images, not performing tests on biological samples to diagnose or monitor a medical condition.
- Device Description: The device is described as a personal computer and monitor system for managing and displaying medical images. It does not involve any components or processes related to analyzing biological specimens.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, calibrators, controls, or any other elements typically associated with in vitro diagnostic devices.
The device functions as a medical image management and display system, which falls under a different regulatory category than IVDs. The predicate and reference devices listed also appear to be image management systems, further supporting this conclusion.
N/A
Intended Use / Indications for Use
CD writer (CD-R STATION) is intended solely for the engraving of DICOM compliant images from a local area network and the CD reader (VRS-2000) is used for viewing the images either from the CD or directly from a local area network.
The media (CD) is not to be used as an archiving media, but rather only as a transportable media to review images and reports. The internal hard disks of the CD-R Station and VRS-2000 are used only for running the software and to temporarily buffer the images / reports to and from the CD and local area network.
Product codes
90 LMD
Device Description
The CD-R STATION & VRS-2000 represents the first generation of Electromed International's CD writer and CD reader stations of digital cardiac images, Componets of "Picture Archiving and Communication System, CFR 892,2050 (CLASS II)". The CD-R STATION & VRS-2000 is intended solely for the engraving of DICOM compliant images from a local area network onto a CD, and for the viewing of the recorded images on the CD.
The CD-R STATION & VRS-2000 is comprised of two principle assemblies: a personal computer and a monitor. The CD-R STATION is to be interfaced to a local area network to receive DICOM compliant images which may then be recorded onto a CD. The VRS-2000 is a stand alone station which reads DICOM compliant images from a CD and displays them on a computer monitor. The media (CD) is not to be used as an archiving media, but rather only as a transportable media to review images and reports. The internal hard disks of the CD-R STATION & VRS-2000 are used only for running the software and to temporarily buffer the images / reports which are to and from the CD. Only the images of a single patient can be transferred to a single CD.
The CD-R STATION & VRS-2000 is to be connected to a 115/230V (+10%), 50/60Hz, 2.6/1.3A power source.
The configurable and add-on options being offered with the CD-R STATION & VRS-2000 is a CD label printer and a optional mobile cart.
Since the CD-R STATION & VRS-2000 can receive information and images in a DICOM compliant format, via a local area network, a CD-R Station may be connected to a VIEW ARCHIVING STATION (510k #K971176) to record the previously archived images onto a transportable media (CD).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
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)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.2020 Medical image communications device.
(a)
Identification. A medical image communications device provides electronic transfer of medical image data between medical devices. It may include a physical communications medium, modems, and interfaces. It may provide simple image review software functionality for medical image processing and manipulation, such as grayscale window and level, zoom and pan, user delineated geometric measurements, compression, or user added image annotations. The device does not perform advanced image processing or complex quantitative functions. This does not include electronic transfer of medical image software functions.(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.
0
Image /page/0/Picture/0 description: The image is a black and white logo. The logo is circular and contains a stylized image of a structure that resembles a bridge or a tower. The structure is composed of geometric shapes, including triangles and horizontal lines. The background of the logo is black, and the structure is white.
ELECTROMED INTERNATIONAL
310, boul. Industriel, St-Eustache (Quebec) Canada J7R
Tel.: (514) 491-2100 Fax: (514) 491-4138
Certified
510(k) NOTIFICATION (CD-R STATION, VRS-2000)
Page: 1
JAN 27 998
APPENDIX C (510(k) SUMMARY)
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
CLASSIFICATION NAME: Componet of "Picture Archiving and Communication System, CFR 892.2050 (CLASS II)"
COMMON OR USUAL NAME: CD writer and CD reader stations of digital cardiac images
PROPRIETARY NAME: CD-R STATION & VRS-2000
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 CD-R STATION & VRS-2000 represents the first generation of Electromed International's CD writer and CD reader stations of digital cardiac images, Componets of "Picture Archiving and Communication System, CFR 892,2050 (CLASS II)". The Cinenet Cardiac Image Network, and the Cardiac Image Management System are complete systems which comprise of the following functions: image archiving; processing; analysis, management; and analysis. The CD-R STATION & VRS-2000 is intended solely for the engraving of DICOM compliant images from a local area network onto a CD, and for the viewing of the recorded images on the CD.
The CD-R STATION & VRS-2000 is comprised of two principle assemblies: a personal computer and a monitor. Unlike the Cinenet Cardiac Image Network which uses digital videocassettes as the archiving media, the CD-R STATION & VRS-2000 does not archive at all. The CD-R STATION is to be interfaced to a local area network to receive DICOM compliant images which may then be recorded onto a CD. The VRS-2000 is a stand alone station which reads DICOM compliant images from a CD and displays them on a computer monitor. The media (CD) is not to be used as an archiving media, but rather only as a transportable media to review images and reports. The internal hard disks of the CD-R STATION & VRS-2000 are used only for running the software and to temporarily buffer the images / reports which are to and from the CD. Only the images of a single patient can be transferred to a single CD, whereas the Cinenet Cardiac Image Network incorporates a Data Storage Library for archival which contains anywhere from 84 to 1008 digital video cassettes for automatic retrieval.
October 24, 1997
1
Image /page/1/Picture/0 description: The image is a black and white logo. The logo is a circle with a design inside of it. The design appears to be a bridge or some other type of structure. The structure has a trapezoidal base and a triangular top.
ELECTROMED INTERNATIONAL
310, boul. Industriel. St-Eustache (Quebec) Canada J7R 5R4
Image /page/1/Picture/2 description: The image shows a logo or emblem with the text "Certified ISO 9001 Certified" arranged in a stacked format. The text is in a bold, slightly distorted font, giving it a textured appearance. The word "Certified" appears twice, once at the top and once at the bottom, sandwiching "ISO 9001" in the middle.
510(k) NOTIFICATION (CD-R STATION, VRS-2000)
Page: 2
APPENDIX C (510(k) SUMMARY)
The CD-R STATION & VRS-2000 is to be connected to a 115/230V (+10%), 50/60Hz, 2.6/1.3A power source.
The configurable and add-on options being offered with the CD-R STATION & VRS-2000 is a CD label printer and a optional mobile cart.
Since the CD-R STATION & VRS-2000 can receive information and images in a DICOM compliant format, via a local area network, a CD-R Station may be connected to a VIEW ARCHIVING STATION (510k #K971176) to record the previously archived images onto a transportable media (CD).
Since the options or combination of options, as stated above, are available as an integral part of the CD-R STATION & VRS-2000, the device will inevitably be offered in various configurations while maintaining the intended use and technological characteristics presented here within.
The CD-R STATION & VRS-2000 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 Department of Health & Human Services USA. The logo features a stylized eagle with three lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
James Riedl Quality Director Electromed International 310 boul. Industrial St. Eustache (Quebec) Canada J7R 5R4
Re:
K974255 CD-R Station and VRS-2000 Dated: November 3, 1997 Received: November 13, 1997 Regulatory class: Unclassified Procode: 90 LMD
JAN 27 1998
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 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 (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS 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 beeing 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 (21 CFR Part 801 and additionally 809.10 for in vitro 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,
Sincerely yours,
W.Liau Yu
Lillian Yin, 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
3
01/20/98 TUE 13:45 FAX 301 480 4224
CDRH DRAERD
Page_ of
510(k) Number (if known):
CD-R Station and VRS-2000 Device Name:
Indications For Use:
CD writer (CD-R STATION) is intended solely for the engraving of DICOM compliant images from a local area network and the CD reader (VRS-2000) is used for viewing the images either from the CD or directly from a local area network.
The media (CD) is not to be used as an archiving media, but rather only as a transportable media to review images and reports. The internal hard disks of the CD-R Station and VRS-2000 are used only for running the software and to temporarily buffer the images / reports to and from the CD and local area network.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) |
|---|
| -------------------------------------------------------- |
David L. Benson
(Division Sign-Off) Division of Reproductive, Abdon and Radiological Devices 510(k) Number
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)