BARCO MEDIS 5MP 5 MEGAPIXEL MEDICAL DIAGNOSTIC DISPLAY SYSTEM

K982820 · Barco NV Display Systems · LLZ · Oct 8, 1998 · Radiology

Device Facts

• Record ID: K982820
• Device Name: BARCO MEDIS 5MP 5 MEGAPIXEL MEDICAL DIAGNOSTIC DISPLAY SYSTEM
• Applicant: Barco NV Display Systems
• Product Code: LLZ · Radiology
• Decision Date: Oct 8, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2

Intended Use

The Barco MeDis 5MP 5 MegaPixel Medical Diagnostic Display System is intended to be used in displaying and viewing digital images for review and analysis by trained medical practitioners.

Device Story

Digital image display system; provides high-resolution visualization of medical images. Used by trained medical practitioners in clinical settings for review and analysis of diagnostic images. Device functions as a workstation monitor to render digital data for clinical decision-making.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

5 MegaPixel medical diagnostic display system; high-resolution visualization components. Specific materials and standards not disclosed.

Indications for Use

Indicated for trained medical practitioners to display and view digital images for review and analysis.

Regulatory Classification

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.

Special Controls

*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).

Predicate Devices

• Barco MWD 321 Medical Workstation Display
• Barco MGD 521 5 MegaPixel Diagnostic Display (K972701)

Submission Summary (Full Text)

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## OCT 8 1038

## 510(k) SUMMARY

Barco NV/Display Systems A. Manufacturer : Theodoor Sevenslaan 106 8500 Kortrijk Belgium

Ferguson Medical Submitted By: Consultant to Barco NV

[phone] Contact Information: Phone: B. [phone] FAX:

- System, digital image ر Classification Name: communication
Image display system, medical image Common/usual Name: workstation, image monitor/display, and others

Barco MeDis 5MP 5 MegaPixel Medical Proprietary Name: Diagnostic Display System

- D. Classification Number: 90LMD
- Barco NV/Display E. Substantial Equivalence: Systems, MWD 321 Medical Workstation Display Barco Barco NV/Display Systems, Barco MGD 521 (K972701), 5 MegaPixel Diagnostic Display, and others.
- The MeDis 5MP device is a digital F. Device Description: image display system.
- 5MP 5 MegaPixel Medical G. Intended Use: The Barco MeDis Diagnostic Display System device is intended to be displaying and viewing digital images for in used review by trained medical practitioners.
- H . Technological Characteristics: The Barco MeDis 5MP 5 MegaPixel Medical Diagnostic Display System device of components to provide high resolution consists visualization of digital images.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 8 1998

Barco NV Display Systems c/o Frank Ferguson Ferguson Medical 2581 California Park Drive, Suite 269 Chico. CA 95928

Re:

K982820 Barco MeDis 5MP 5 MegaPixel Medical Diagnostic Display System Dated: May 20, 1998 Received: August 11, 1998 Regulatory class: II 21 CFR 892.2050/Procode: 90 LLZ

Dear Mr. Ferguson:

We have reviewed your Section 510(k) and intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for usestated 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 Federal Pood Drug, and Cosmetic Actor Your may, therefore, market the device, subject to the general controls provisions of the general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, abblings 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 maior 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 requirements, as set forth in the Quality System Regulation (OS) for Medicals Devices: «Generalregulation (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 yitn 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/odri/dsmaldsmamain.html".

Sincerely yours,

William Yu

Lillian Yin, Ph.D Director, Division of Reproductive Abdominal, Ear, Nose and Throa and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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)510(k) Number (If known): 【(982820

Barco MeDis 5MP 5 MegaPixel Medical Diagnostic Device Name: Display System

Indications For Use:

The Barco MeDis 5MP 5 MegaPixel Medical Diagnostic Display System is intended to be used in displaying and viewing digital images for review and analysis by trained medical practitioners.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

David A. Segerson
(Division Sign-Off)

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

Prescription Use ้ (Per 21 CFR 801.109)

Over-The-Counter Use _

(Optional Format 1-2-96)

OR