(146 days)
Not Found
Not Found
No
The summary describes a standard PACS system for image management and review, with no mention of AI, ML, or advanced image processing features typically associated with such technologies.
No
The device is a Picture Archiving and Communication System (PACS) intended for the electronic management of medical images (acquisition, storage, distribution, and review). It facilitates the handling of medical records to improve efficiency but does not directly provide therapy or treatment.
Yes
The device is described as a "primary diagnostic reading station" that enables "full Radiological interpretation Images," indicating its role in the diagnostic process.
No
The device is described as a "Network System" and a "Picture Archiving and Communication System (PACS)". While it involves software for managing images, the description implies a system that includes hardware components for acquisition, storage, distribution, and review (e.g., servers, workstations, network infrastructure). The summary does not explicitly state it is software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Function: The described device is a PACS (Picture Archiving and Communication System). Its primary function is the electronic management of medical images (acquisition, storage, distribution, and review). It deals with images generated by medical modalities, not with analyzing biological samples.
- Intended Use: The intended use clearly states its purpose is for managing medical images for radiological interpretation. This is distinct from performing diagnostic tests on biological specimens.
Therefore, the device falls under the category of medical imaging management systems, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The Network System is intended to provide electronic management of the acquisition, storage, distribution and review of Medical Images. Management activities include: Acquisition the Network System from all medical modalities and digitized films. Storage archive is managed by a database. Distribution and wide area networks based on standard TCP protocols. Review Reading Station (MMRS), the primary diagnostic reading station. The reading station has all necessary functions to enable full Radiological interpretation Images.
Product codes
90 LLZ
Device Description
The Network System is a Picture Archiving and Communication System (PACS). The system is intended to computerize Medical Image handling in Medical institutions. The computerization of the Medical records improves the efficiency of Medical Record handling and thus has a positive effect on Medical practice.
The Network System is intended to provide electronic management of the acquisition, storage, distribution and review of Medical Images.
Acquisition: the Network System from all medical modalities and digitized films.
Storage: archive is managed by a database.
Distribution: and wide area networks based on standard TCP protocols.
Review: Reading Station (MMRS), the primary diagnostic reading station. The reading station has all necessary functions to enable full Radiological interpretation Images.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Medical modalities and digitized films
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Medical institutions
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)
Not Found
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
JUN 17 1998
SUMMARY OF SAFETY AND EFFECTIVENESS
This summary of safety and effectiveness information is being submitted in accordance with the requirements of the SMDA 1990 and 21 CFR 807 92.
Submitter: Medical SNI Ltd. POB 25370 Haifa ISRAEL tel. +972.4.842.6192
Name of the Device: The Network System.
Description of the Device:
and Communication System (PACS). The system is intended to computerize Medical Image handling in Medical institutions. The computerization of the Medical records improves the efficiency of Medical Record handling and thus has a positive effect on Medical practice.
The Network System is intended to provide electronic management of the acquisition, storage, distribution and review of Medical Images.
Acquisition
the Network System from all medical modalities and digitized films.
Storage
archive is managed by a database.
Distribution
and wide area networks based on standard TCP protocols.
Review
Reading Station (MMRS), the primary diagnostic reading station. The reading station has all necessary functions to enable full Radiological interpretation Images.
The Network System is shown schematically in the figure below:
Image /page/0/Figure/20 description: The image shows a diagram with four boxes connected by arrows and a horizontal line. The top left box is labeled "Input Data Digital Modalities", and the top right box is labeled "Input Data Digital X - Ray". The bottom left box is labeled "Archive", and the bottom right box is labeled "MMRS". The arrows indicate the flow of data between the boxes.
1
Image /page/1/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, resembling a bird-like shape.
ి ప్రాథమిక
శాశాల
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
す
JUN 1 7 1998
Eli M. Orbach, Ph.D. International Regulatory Consultants Medical SNI LTD POB 6718, ERFRAT 90435 ISRAEL Re:
K980234 The Network System (Picture archiving and communications system Dated: May 28, 1998 Received: June 1, 1998 Regulatory class: II 21 CFR 892.2050/Procode: 90 LLZ
Dear Dr. Orbach:
We have reviewed your Section 510(k) 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 enactment 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 II (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 substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS inspections, the Food and Drue 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 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 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/cdr/dsmaldsmamain.html".
Sincerely vours
sincerely yours,
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
ﺘ
Page_ of_
510(k) Number (if known) K980234
Device Name The Network System
Indications For Use:
The Network System is intended to provide electronic management of the acquisition, storage, distribution and review of Medical Images. Management activities include:
Acquisition
the Network System from all medical modalities and digitized films.
Storage
archive is managed by a database.
Distribution
and wide area networks based on standard TCP protocols.
Review
ਗਈ ਹੈ।
ਬਹੁਤੀ
ਸਾਰਨ
Reading Station (MMRS), the primary diagnostic reading station. The reading station has all necessary functions to enable full Radiological interpretation Images.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
David C. Segerson
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT and Radiological Dey
510(k) Number KY80234
OR
Prescription Use (Per 21 CFR 801.109)
Over The Counter Use
(Optional Format 1-2-96)