(90 days)
Not Found
Not Found
No
The description focuses solely on the device's function as a communication gateway for transferring DICOM images, with no mention of AI, ML, image processing, or performance studies related to algorithmic analysis.
No.
The device is described as a software communication tool for transferring medical images, not for treating or diagnosing medical conditions.
No
The device is described as a "communication tool" and "communication gateway" that "facilitates the transfer of medical images." It does not mention any function related to analyzing, interpreting, or diagnosing medical conditions from the images.
Yes
The device description explicitly states it is a "software device" and its function is solely related to communication and transfer of medical images, which are software-based operations within a network environment. There is no mention of any hardware components being part of the device itself.
Based on the provided information, the IMNET DICOM Network Agent is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's a "communication tool which facilitates the transfer of medical images from one system to another." It acts as a "communication gateway" for DICOM data.
- Device Description: The description reiterates its function as a software device for transferring medical images.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue) from the human body to provide information for diagnosis, monitoring, or screening. The IMNET DICOM Network Agent does not perform any analysis or examination of biological specimens. It simply handles the transfer of image data.
Therefore, the IMNET DICOM Network Agent falls under the category of medical imaging software that facilitates data management and transfer, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The IMNET DICOM Network Agent is a software device intended for use within the medical imaging environment. The product is a communication tool which facilitates the transfer of medical images from one system to another. Receiving medical images from a DICOM source and transmitting them to another DICOM compatible target, the product is a communication gateway for the DICOM environment.
Product codes
90 LMD
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.2020 Medical image communications device.
(a)
Identification. A medical image communications device provides electronic transfer of medical image data between medical devices. It may include a physical communications medium, modems, and interfaces. It may provide simple image review software functionality for medical image processing and manipulation, such as grayscale window and level, zoom and pan, user delineated geometric measurements, compression, or user added image annotations. The device does not perform advanced image processing or complex quantitative functions. This does not include electronic transfer of medical image software functions.(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
Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features the department's name arranged in a circular pattern around a symbol. The symbol consists of a stylized caduceus-like design with three wavy lines converging at the bottom.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 2 3 1997
William Bain Associate General Counsel Imnet Systems, Inc. 3015 Winward Plaza Winward Fairway II Alphearetta, GA 30202
Re:
Imnet Dicom Network Agent Dated: June 24, 1997 Received: June 25, 1997 Regulatory class: Unclassified Procode: 90 LMD
Dear Mr. Bain:
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 intenstated 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, 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 Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) 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 531 through 542 of the Act for devices under Radiation Control grovisions, 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,
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
1
EXHIBIT G : USE FORM
Page 1 of 1
510(k) Number (if known): Not assigned yet
Device Name: IMNET® DICOM Network Agent
Indications for Use:
The IMNET DICOM Network Agent is a software device intended for use within the medical imaging environment. The product is a communication tool which facilitates the transfer of medical images from one system to another. Receiving medical images from a DICOM source and transmitting them to another DICOM compatible target, the product is a communication gateway for the DICOM environment.
(PLEASE DO NOT WRITE BELOW THIS LINE. CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
1 Prescription Use
OR Over-The-Counter Use
(Per 21 CFR 801.109
(Optional Format 1-2-96)
Thind G. Seymann
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 172366 510(k) Number
IMNET Systems CONFIDENTIAL