(57 days)
Not Found
No
The description focuses on standard PACS functionalities (storage, communication, display, basic processing) and does not mention AI or ML.
No
The device is described as a Picture Archiving and Communication System (PACS) that receives, stores, communicates, processes, and displays medical images and data. It does not produce any original medical images nor does it directly treat or affect a disease or condition; its function is related to image management for diagnostic purposes.
No.
The device specifically states it does not produce any original medical images and focuses on storage, communication, processing, and display of received images, which are functions of a Picture Archiving and Communication System (PACS) rather than direct diagnosis.
Yes
The device description explicitly states that INTEGRADWeb™ is an "Internet based software picture archiving and communications system" and that it "utilizes commercially available computer platforms" and "does not produce any original medical images." This indicates it is a software-only solution for managing and displaying existing medical images.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Function: The description of INTEGRADWeb™ clearly states that it is a system for receiving, storing, communicating, processing, and displaying medical images from various imaging modalities (CT, MR, X-ray, etc.). It does not perform any tests on biological specimens.
- Input: The input to the system is medical images, not biological samples.
Therefore, INTEGRADWeb™ falls under the category of medical imaging software or a Picture Archiving and Communication System (PACS), not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
INTEGRADWeb™ by Dynamic Imaging, Inc. is a device that receives medical images and data from various imaging sources. Images and data can be stored, communicated, processed and displayed within the system or across computer networks at distributed locations. Typical users of this system are trained professionals, as in physicians, nurses, and technicians.
Product codes
LLZ
Device Description
INTEGRADWeb™ is an Internet based software picture archiving and communications system that provides users with capabilities relating to the acceptance, transfer, display, storage, and digital processing of medical images. INTEGRADWeb™ includes features to access and manage medical imaging studies from cat-scan (CT), magnetic radiography (MR), ultrasound (US), nuclear medicine (NM), computerized radiography (CR), digital radiography (DR), digital x-ray (DX), x-ray angiography (XA), PET scan (PT), and other imaging modalities. INTEGRADWeb™ is designed to be deployed over conventional TCP/IP networking infrastructure available in most healthcare organizations, and utilizes commercially available computer platforms (Intel Pentium-based) and operating systems (Microsoft Windows 2000, Windows NT, and Windows 98). The system does not produce any original medical images. All images located on INTEGRADWeb™ have been received from DICOM compliant modalities and/or systems.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
cat-scan (CT), magnetic radiography (MR), ultrasound (US), nuclear medicine (NM), computerized radiography (CR), digital radiography (DR), digital x-ray (DX), x-ray angiography (XA), PET scan (PT), and other imaging modalities.
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Typical users of this system are trained professionals, as in physicians, nurses, and technicians.
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
Not Found
Key Metrics
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).
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Image /page/0/Picture/0 description: The image contains a sequence of numbers and letters. The sequence is "K03/3//". The characters are written in a handwritten style.
JUN 2 0 2003
Dynamic Imaging, Inc.
Page 1
510(k) Summary of Safety and Effectiveness
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990.
Date Prepared: April 2, 2003
Submitter's Information: 21 CFR 807.92(a)(1) Dynamic Imaging, Inc. 110 Commerce Drive Allendale, NJ 07401
Trade Name, Common Name and Classification: 21 CFR 807.92(a)(2) INTEGRADWeb™ by Dynamic Imaging, Inc. Trade Name: Common Name: Picture Archiving Communications System 892.2050 Device Classification: System, Image Processing Name:
Predicate Device: 21 CFR 807. 92(a)(3)
Device Classification Name SYSTEM, IMAGE SYSTEM, IMAGE PROCESSING,
| Regulation Number | 892.2050 |
|---|---|
| 510(k) Number | K013630 |
| Device Name | ISITE RADIOLOGY |
| Applicant | STENTOR, INC. |
| 16303 PANORAMIC WAY | |
| SAN LEANDRO, CA 94578 | |
| Product Code | LLZ |
| Decision Date | 12/05/2001 |
Device Description: 21 CFR 807 92(a)(4)
INTEGRADWeb™ is an Internet based software picture archiving and communications system that provides users with capabilities relating to the acceptance, transfer, display, storage, and digital processing of medical images. INTEGRADWeb™ includes features to access and manage medical imaging studies from cat-scan (CT), magnetic radiography (MR), ultrasound (US), nuclear medicine (NM), computerized radiography (CR), digital radiography (DR), digital x-ray (DX), x-ray angiography (XA), PET scan (PT), and other imaging modalities. INTEGRADWeb™ is designed to be deployed over conventional TCP/IP networking infrastructure available in most healthcare organizations, and utilizes commercially available computer platforms (Intel Pentium-based) and operating systems (Microsoft Windows 2000, Windows NT, and Windows 98).
1
Image /page/1/Picture/0 description: The image shows the logo for Dynamic Imaging, Inc. The logo features a stylized letter "D" with a black square above it. The text "Dynamic Imaging, Inc." is written in a simple, sans-serif font below the logo. The logo is black and white.
The system does not produce any original medical images. All images located on INTEGRADWeb™ have been received from DICOM compliant modalities and/or systems.
Indications for Use: 21 CFR 807 92(a)(5)
INTEGRADWeb™ by Dynamic Imaging, Inc. is a device that receives medical images and data from various imaging sources. Images and data can be stored, communicated, processed and displayed within the system or across computer networks at distributed locations. Typical users of this system are trained professionals, as in physicians, nurses, and technicians.
Technological Characteristics: 21 CFR 807 92(a)(6)
The device is medical device image software that is used with computer hardware in a picture archiving and communications system user environment. The device does not contact the patient, nor does it control any life sustaining devices. A physician, providing ample opportunity for competent human intervention interprets images and information being displayed and printed.
Conclusion: 21 CFR 807 92(b)(1)
The 510(k) Pre-Market Notification INTEGRADWeb™ contains adequate information and data to enable FDA - CDRH to determine substantial equivalence to the predicate device. The system has been and will be manufactured in accordance with the voluntary standards listed in the enclosed voluntary standard survey. The submission contains the results of a hazard analysis and the potential hazards have been classified as Minor.
2
Image /page/2/Picture/1 description: The image is a black and white logo. The logo features a stylized bird with three curved lines representing its body and wings. The bird is positioned within a circle, and the text "United States Environmental Protection Agency" is written around the circumference of the circle. The text is in a simple, sans-serif font and is arranged to follow the curve of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 2 0 2003
Dynamic Imaging, Inc. % Mr. Carl Alletto Consultant OTech, Inc. 1100 Lakeview Blvd. DENTEN TX 76208
Re: K031311
Trade/Device Name: INTEGRADWebTM Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communication system Regulatory Class: II Product Code: 90 LLZ Dated: March 19, 2003 Received: April 30, 2003
Dear Mr. Alletto:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.
3
Page 2
This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of the letter:
| 8xx. 1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
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" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
15031311
Page 1 of -1
(Indications for Use Form)
510(k) Number:
Device Name:
INTEGRADWeb™ by Dynamic Imaging, Inc.
Indications for Use:
INTEGRADWeb™ by Dynamic Imaging, Inc. is a device that receives medical images and data from various imaging sources. Images and data can be stored, communicated, processed and displayed within the system or across computer networks at distributed locations. Typical users of this system are trained professionals, as in physicians, nurses, and technicians.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF
NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
OR
Over-The-Counter Use
(Per 21 CFR 801.109)
(Optional Format 1-2-96)
David B. Segmen