(66 days)
Not Found
No
The summary explicitly states "Mentions AI, DNN, or ML: Not Found" and the description focuses on image management and display, not advanced analytical capabilities typically associated with AI/ML.
No.
The device is solely for the management and display of medical images and information, not for applying therapy or directly impacting patient health outcomes.
No
Explanation: The device is intended for the management and displaying of x-ray images and other radiological objects, not for diagnosis. It processes and manages existing images but does not actively generate new diagnostic information or interpretations.
Yes
The device description focuses solely on the management and display of images and information, interfacing with existing hardware (modalities, servers, RIS, storage, printing devices) using software standards (DICOM). There is no mention of new or included hardware components.
Based on the provided information, the SECTRA AB, WISE Image Management System is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the management and displaying of x-ray images and other radiological objects. This involves handling and presenting medical images, not analyzing biological samples or performing tests on them.
- Device Description: The description reinforces its role in managing radiological images.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, performing tests, or providing diagnostic information based on in vitro analysis.
IVD devices are specifically designed to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device deals with medical images, which are acquired in vivo (within the living body) and then managed and displayed.
N/A
Intended Use / Indications for 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.
Product codes
90 LMB
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
x-ray images, other radiological objects
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
The typical users are trained medical professionals at a radiology department.
Typical users of this system are trained professionals, including but not limited to physicians, radiologists, nurses, medical technicians, and assistants.
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)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.2010 Medical image storage device.
(a)
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.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 892.9.
0
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:
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- WISE is subject to and in compliance with the Federal Performance Standards, defined in 21 CFR, part 1000.
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- WISE has been and will be manufactured in accordance with the voluntary standards listed in the enclosed voluntary standard survey.
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- WISE User's Guides contains comprehensive and extensive information on how to operate the system to ensure a safe and effective use.
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- The submission contains the results of an hazard analysis.
Texte And
Peter Andersson Regulatory Manager SECTRA-Imtec AB Linköping, Sweden Telephone: +46 13 23 52 00
1
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 (301) 594-4591 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 (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,
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
2
Page 1 of -1
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.
(PLEASE DO NOT WRITF. BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
ાર
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.