WISE IMAGE MANAGEMENT SYSTEM

K971451 · O Tech, Inc. · LMB · Jun 26, 1997 · Radiology

Device Facts

• Record ID: K971451
• Device Name: WISE IMAGE MANAGEMENT SYSTEM
• Applicant: O Tech, Inc.
• Product Code: LMB · Radiology
• Decision Date: Jun 26, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2010
• Device Class: Class 1
• Attributes: Software as a Medical Device

Intended Use

The SECTRA AB, WISE Image Management System device is intended for the management and displaying of x-ray images, other radiological objects, and information. It can manage images from different modalities, single and multiple file servers, and interfaces to various Radiological Information Systems (RIS), image storage and printing devices using DICOM or similar interface standards. Typical users of this system are trained professionals, including but not limited to physicians, radiologists, nurses, medical technicians, and assistants.

Device Story

WISE Image Management System manages and displays radiological images and associated data. Inputs include x-ray images and data from various radiological modalities, file servers, and Radiological Information Systems (RIS). The system interfaces with storage and printing devices using DICOM or similar standards. Operated by trained medical professionals (radiologists, physicians, nurses, technicians) in clinical environments, the system facilitates image viewing and data management. It supports clinical decision-making by providing access to diagnostic images and patient information. Benefits include streamlined radiological workflow and centralized image access.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Radiological image management system. Interfaces with modalities, RIS, and storage/printing devices via DICOM or similar standards. Software-based system for image display and management. Compliance with 21 CFR Part 1000 and voluntary manufacturing standards.

Indications for Use

Indicated for the management and display of radiological images and information by trained medical professionals, including physicians, radiologists, nurses, and technicians, in a clinical setting.

Regulatory Classification

Identification

A medical image storage device is a hardware device that provides electronic storage and retrieval functions for medical images. Examples include electronic hardware devices employing magnetic and optical discs, magnetic tapes, and digital memory.

Predicate Devices

• SECTRA-Imtec ImageServer 2000 (K963395)

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

17 April 1997 K971451

SECTRA Doc. no: 3-97.434-2.0

## 510(k) summary of safety and effectiveness information for the SECTRA-Imtec WISE Image Management System

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

WISE will be used for management 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 ImageServer 2000 (K963395). This information and data is summarised as follows:

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

Texte 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 Oosterwijki President Otech Inc. 6741 Grant Lane Plano, TX 75024

Re: K971451

Wise Image Management System … · Date: April 17, 1997 Received: April 21, 1997 Regulatory class: Unclassified Procode: 90 LMB

Dear Mr. Oosterwijk:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have decemined 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 enactions date of the Medical Device Amendances 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 of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions 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 substanially equivalent decemination 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 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 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 510(k) premarket nouthcaion. 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 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 Y

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: K971451

Device Name: WISE Image Management System

Indications For Usc:

The SECTRA AB, WISE Image Management System device is intended for the management and displaying of x-ray images, other radiological objects, and information.

It can manage images from different modalities, single and multiple file servers, and interfaces to various Radiological Information Systems (RIS), image storage and printing devices using DICOM or similar interface standards.

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

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

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Over -The-Counter Use ________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

David A. Seymore

(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devic 510(k) Number.