THE MIDVIEW-MEDCON'S DICOM VIEWER

K971181 · Medcon , Ltd. · IZI · Jul 29, 1997 · Radiology

Device Facts

• Record ID: K971181
• Device Name: THE MIDVIEW-MEDCON'S DICOM VIEWER
• Applicant: Medcon , Ltd.
• Product Code: IZI · Radiology
• Decision Date: Jul 29, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1600
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

The MOVIEW 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 in real-time mode.

Device Story

MDVIEW is a software-based DICOM viewer for cardiac catheterization laboratory images. Input: cardiac catheterization image studies stored on CD-R media in DICOM format. Operation: software retrieves, displays, prints, and saves images on a standard PC in real-time mode. Usage: clinical setting; operated by physicians for diagnostic review and analysis. Benefit: provides physicians with tools for viewing loss-free digital images to assist in clinical decision-making regarding cardiac catheterization studies.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Software-based DICOM viewer; operates on standard PC hardware; supports DICOM standard for image retrieval and display; loss-free image processing.

Indications for Use

Indicated for use by physicians to retrieve, display, print, and save cardiac catheterization laboratory image studies from CD-R media for diagnostic review and analysis.

Regulatory Classification

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.

Predicate Devices

• CRS 2000 subsystem of the Kodak Science Digital Image System

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
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 29 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 II (Special Controls) or 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 the Electronic Product 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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,


Enclosure

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# 5. SUMMARY OF SAFETY AND EFFECTIVENESS

JUL 29 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.

$$1 < 971181$$

Submitter: Medcon Ltd. Kiryat Atidim, P.O. Box 518164 Tel Aviv 61581 Israel Tel: [phone], Fax: [phone]

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

Date


Medcon Ltd. TELEMETRICS TECHNOLOGY

FDA/MDVIEW/510(K)

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Page 2 of 2

510(k) Number (if known): K971181

Device Name: The MOVIEW-MEDCON'S DICOM VIEWER

Indications For Use:

The MOVIEW 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 in real-time mode.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use ☐
(Per 21 CFR 801.109)

OR

Over-The-Counter Use ☐
(Optional Format 1-2-96)


(Division of Reproductive, Abdominal, ENT, and Radiological Devices
510(k) Number K971181