(120 days)
Not Found
No
The description focuses on standard image retrieval, display, printing, and saving functionalities of cardiac catheterization images in DICOM format. There is no mention of AI, ML, or any advanced analytical capabilities that would typically involve these technologies.
No.
The device is described as software for retrieving, displaying, printing, and saving cardiac catheterization laboratory images for diagnostic review and analysis by physicians. It does not exert a therapeutic effect on a patient.
No
The provided text states the device is intended for "diagnostic review and analysis" of cardiac images, but its primary function is to retrieve, display, print, and save images. It doesn't interpret or analyze images to provide a diagnosis itself.
Yes
The device description explicitly states "The MDVIEW is a software device intended to retrieve, display, print and save cardiac catheterization laboratory image studies from CD-R media, and to view these images on a PC computer in real time mode." It focuses solely on software functionalities for image handling and display.
Based on the provided information, the MOVIEW device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- MOVIEW's Function: The MOVIEW software is described as a device that retrieves, displays, prints, and saves cardiac catheterization laboratory image studies. It works with digital images recorded on CD-R media.
- Nature of the Input: The input is imaging data (digital images), not biological samples from the body.
Therefore, the MOVIEW device falls under the category of medical imaging software, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The MDVIEW is a software device intended to retrieve, display, print and save cardiac catheterization laboratory image studies from CD-R media, and to view these images on a PC computer in real time mode.
Product codes
90 IZI
Device Description
The MDVIEW is a software device intended to retrieve, display, print and save cardiac catheterization laboratory image studies from CD-R media, and to view these images on a PC computer in real time mode. Digital imaging from the cardiac catheterization laboratory is recorded on the CD-R in conformance with the DICOM standard. These loss free images provide physicians with a valuable tool for diagnostic review and analysis. The differences between the MDVIEW and the predicate device raise no new issues of safety or effectiveness.
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)
The CRS 2000 subsystem of the Kodak Science Digital Image System.
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH" is arranged in a semi-circular fashion around the left side of the emblem.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MEDCON LTD. c/o Dr. Eli M. Orbach International Regulatory Consultants POB 6718, Erfrat 90435 ISRAEL
Re: K971181 MDVIEW (PACS) Medical Image Communication and Storage Device (Cardiac Device Accessory) Dated: July 14, 1997 Received: July 16, 1997 Regulatory Class: II 21 CFR 892.1600/Procode: 90 IZI
JUL 2 9 1997
Dear Dr. Orbach:
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, market the device, 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 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 (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 questions on the promotion 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.J.Liau Yin
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
1
SUMMARY OF SAFETY AND EFFECTIVENESS 5.
9 1997
This summary of safety and effectiveness information is being submitted in accordance with the requirements of the SMDA 1990 and 21 CFR 807.92.
Submitter: Medcon Ltd. Kiryat Atidim, P.O. Box 518164 Tel Aviv 615811srael Tel: +972.3 6487702, Fax: +972. 3 6482310
Name of the Device: The MDVIEW-MEDCON's DICOM Viewer
Predicate Devices: The MDVIEW is substantially equivalent to The CRS 2000 subsystem of the Kodak Science Digital Image System. ...
Description of the Device: The MDVIEW is a software device intended to retrieve, display, print and save cardiac catheterization laboratory image studies from CD-R media, and to view these images on a PC computer in real time mode. Digital imaging from the cardiac catheterization laboratory is recorded on the CD-R in conformance with the DICOM standard. These loss free images provide physicians with a valuable tool for diagnostic review and analysis. The differences between the MDVIEW and the predicate device raise no new issues of safety or effectiveness.
24 March, 1997
y
Mr.Uzi Blumensohn, General Manager
Date
Image /page/1/Picture/10 description: The image shows the logo for Medcon Ltd. The logo is black and white and features the company name in a bold, sans-serif font. Below the company name is the tagline "TELEMEDICINE TECHNOLOGY" in a smaller font. The logo is simple and professional, and it conveys the company's focus on telemedicine technology.
2
Page__________________________________________________________________________________________________________________________________________________________________________
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________ MOVIEW - MEDION'S DICOM INEWER Indications For Use: The MOVIEW is a software device vicently , print and save cardia.
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Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use X
(Per 21 CFR 801.109)
OR
Over-The-Counter Use __
(Optional Format 1-2-96)
(Division Sign Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number K971181
Luy