(151 days)
No
The summary describes standard image processing and display functionalities common to diagnostic workstations of that era, with no mention of AI or ML terms or capabilities.
No
The device is described as an "independent diagnostic viewing and processing workstation" for radiological images. Its functions are related to archiving, displaying, manipulating, and processing images, which are diagnostic activities, not therapeutic ones.
Yes
The "Intended Use / Indications for Use" states that "ProVision is an independent diagnostic viewing and processing workstation." The "Device Description" also refers to it as a "multi-modality diagnostic Workstation."
No
The device description explicitly states it is based on "off-the shelf Silicon Graphics UNIX based computers," indicating it includes hardware components in addition to the software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- ProVision's function: ProVision is described as a diagnostic viewing and processing workstation for radiological images from modalities like CT, MRI, etc. It processes and displays images obtained from the body, not samples taken from the body.
- No mention of biological samples: The description focuses entirely on image processing and display, with no mention of analyzing biological samples.
Therefore, ProVision falls under the category of medical imaging software/workstations, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The systems is intended for use by radiologists as an interactive tool for analyzing radiological data.
ProVision is an independent diagnostic viewing and processing workstation. It is based on a Silicon Graphics Workstation running under Unix. ProVision communicates with imaging systems of different modalities (currently CT, MRI, CR, RF, NM) utilizing the DICOM - 3 standard. Connection may also be made to any other DICOM device.
ProVision functions include :Archiving, displaying, manipulation, filming, 2and 3-dimensional processing. ProVision employs a graphical multi -Window, icon and mouse driven user interface. It is designed to ensure maximum flexibility on the one hand, and intuitive operation on the other.
Product codes
90 LLZ
Device Description
The ProVision is a multi-modality diagnostic Workstation for processing and archiving radiological images. It is based on off-the shelf Silicon Graphics UNIX based computers that comply with the accepted international standards for computer systems. The systems also comprises software developed and validated by Algotec Systems Ltd.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
currently CT, MRI, CR, RF, NM
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
radiologists
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
§ 892.2050 Medical image management and processing system.
(a)
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.(b)
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).
0
JUL 20 1998
Summary Of Safety and Effectiveness 2
This summary of 510(k) safety and Effectiveness information is being submitted in accordance with the requirements of the SMDA 1990 and 21 CFR 807.92.
Submitter :
Algotec systems Ltd. 4 Hamelacha St. P.O Box 2408 Industrial zone Raanana ISRAEL 43000 Tel : +972 - 9 - 7482442 Fax : +972 - 9 - 7482411
Name of the Device: Software updates on ProVision.
Predicate Device : ProVision diagnostic Workstation Manufactured by Algotec Systems Ltd.(K954678).
-
Description of the Device: The ProVision is a multi-modality diagnostic Workstation for processing and archiving radiological images. It is based on off-the shelf Silicon Graphics UNIX based computers that comply with the accepted international standards for computer systems. The systems also comprises software developed and validated by Algotec Systems Ltd.
Intended use: The systems is intended for use by radiologists as an interactive tool for analyzing radiological data. -
Comparison of Technological Characteristics: The new updates made on the Provision workstation share the same software and hardware backbone as the original applications. They are an inherent part of the workstation and share the identical system resources. The new updates simply provide quicker methods to reach results that would have been time consuming on the previous version of Pro Vision software.
The addition of these software updates raises no new issues of safety or effectiveness.
February 10, 1998
DR Menashe Benjamin, President
1980648-
Date
Signature, Title
Meher Bey
1
Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines forming its body and wings. The eagle is enclosed in a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper half of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 20 1998
Algotec Systems, LTD c/o Eli M. Orbach International Regulatory Consultants P.O. Box 6718 Efrat 90435 Israel
Re:
K980648 ProVision (Diagnostic Workstation) Dated: May 27, 1998 Received: May 29, 1998 Regulatory class: II 21 CFR 892.2050/Procode: 90 LLZ
Dear Dr. Orbach:
We have reviewed your Section 5100k) 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 exactment 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 III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Felections, Title 21. Parts 800 to 895. A substantially equivaliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) 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 542 of the Act for derices 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 (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the 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,
Kilian Yin, Ph.D.
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
510 (K) Number (if known):K980648
Device Name: ProVision Workstation
Indications for use:
ProVision is an independent diagnostic viewing and processing workstation. It is based on a Silicon Graphics Workstation running under Unix. ProVision communicates with imaging systems of different modalities (currently CT, MRI, CR, RF, NM) utilizing the DICOM - 3 standard. Connection may also be made to any other DICOM device.
ProVision functions include :Archiving, displaying, manipulation, filming, 2and 3-dimensional processing. ProVision employs a graphical multi -Window, icon and mouse driven user interface. It is designed to ensure maximum flexibility on the one hand, and intuitive operation on the other.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Daniel A. Seggern
(Division Sign-Off)
Division of Reproductive, Abdominal and Radiological De 510(k) Number
Prescription use _ × (Per 21 CFR 801.109)
OR
Over The Counter Use_ Format 1-2-96) (Optional