IDS4 IMAGE DISPLAY SYSTEM SERIES

K971368 · O Tech, Inc. · LLZ · Jun 26, 1997 · Radiology

Device Facts

• Record ID: K971368
• Device Name: IDS4 IMAGE DISPLAY SYSTEM SERIES
• Applicant: O Tech, Inc.
• Product Code: LLZ · Radiology
• Decision Date: Jun 26, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2

Intended Use

The SECTRA MS4 device is intended for the manipulation and displaying of x-ray images. It can show images from different modalities and interfaces to various image storage and printing devices using DICOM or similar interface standards. Device options make possible telecommunications; fast demonstration; prosthesis CAD; 3-D and angiography, etc .; and teleconferencing. Typical users of this system are trained professionals, including but not limited to physicians, radiologists, nurses, medical technicians, and assistants.

Device Story

IDS4 Image Display System; workstation for radiological image management. Inputs: x-ray images from various modalities via DICOM or similar interfaces. Processing: image manipulation, display, and routing to storage or printing devices. Features: telecommunications, fast demonstration, prosthesis CAD, 3-D reconstruction, angiography, and teleconferencing. Used in radiology departments by trained professionals (physicians, radiologists, nurses, technicians). Output: visual display of medical images for clinical review. Benefit: facilitates efficient image handling, diagnostic review, and collaborative consultation.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on bench testing, hazard analysis, and compliance with established performance and manufacturing standards.

Technological Characteristics

Radiological image display workstation. Connectivity via DICOM or similar interface standards. Supports 3-D imaging, angiography, and prosthesis CAD. Manufactured in accordance with voluntary standards and 21 CFR Part 820 (GMP).

Indications for Use

Indicated for trained medical professionals, including physicians, radiologists, nurses, and technicians, for the display and manipulation of x-ray images from various modalities.

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

• SECTRA-Imtec TRS 2000 (K961983)

Submission Summary (Full Text)

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Department of Health and Human Services Center for Devices and Radiological Health Office of Device Evaluation Pre-Market Notification Section

21 March 1997 K971368

SECTRA Doc. no: 3-97.202-1.0

JUN 26 1997

## 510(k) summary of safety and effectiveness information for the SECTRA-Imtec IDS4 Image Display System series

This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990.

The IDS4 series will be used for displaying and handling of radiological images. The typical users are trained medical professionals at a radiology department.

The undersigned certifies that the 510(k) Pre-Market Notification for the above referenced product contains adequate information and data to enable CDRH to determine substantial equivalence to SECTRA-Imtec TRS 2000 (K961983). This information and data is summarised as follows:

- 1. The IDS4 series is subject to and in compliance with the Federal Performance Standards, defined in 21 CFR, part 1000.
- 2. The IDS4 series has been and will be manufactured in accordance with the voluntary standards listed in the enclosed voluntary standard survey.
- 3. The IDS4 series User's Guides contains comprehensive information on how to operate the system to ensure a safe and effective use.
- 4. The submission contains the results of an hazard analysis.

Pet And

Peter Andersson Regulatory Manager SECTRA-Imtec AB Linköping, Sweden Telephone: [phone]

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## JUN 26 1997

Sectra-Imtec AB c/o Herman Oosterwiiki President Otech, Inc. 6741 Grant Lane Plano, TX 75024

Re: K971368 IDS4 Image Display System Series Dated: April 9, 1997 ... ... Received: April 14, 1997 Regulatory class: Unclassified Procode: 90 LLZ

Dear Mr. Oosterwijki:

We have reviewed your Secsion 510(k) notification of intent to market the device and we have desemined 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 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 precise, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Premates 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 equivalion assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP 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 Feceral Register. Please note: this response to your premarket notification does not affect any obligation you might have under sections 51 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(t) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predication 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] for Radiology devices, or 594-4613 for Ear, Nose and Throat devices. 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,

William Yu

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

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510(k) Number: K971368

Device Name: IDS4 (Image Display System), by SECIRA-Imtec AB

Indications For Use:

The SECTRA MS4 device is intended for the manipulation and displaying of x-ray images. It can show images from different modalities and interfaces to various image storage and printing devices using DICOM or similar interface standards.

Device options make possible telecommunications; fast demonstration; prosthesis CAD; 3-D and angiography, etc .; and teleconferencing.

Typical users of this system are trained professionals, including but not limited to physicians, radiologists, nurses, medical technicians, and assistants.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Pcr 21 CFR 801.109) OR

Over -The-Counter Use

(Optional Format 1-2-96)

David A. Sejmon
(Division Sign-Off)

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