(70 days)
Not Found
Not Found
No
The summary describes standard medical imaging processing and viewing tools, with no mention of AI, ML, or related concepts.
No
The device is described as a medical imaging and information solution for viewing and processing images, not for providing therapy or treatment.
Yes
The device is described as a "radiology viewing station" and "a complete medical imaging and information solution" that allows users to handle and process patient data, including images, from various medical imaging modalities. It specifically mentions "image processing tools, filters, annotations, measurements, windowing and display functions" which are all key features of a diagnostic viewing and analysis system. The mention of "Lossy compressed mammographic images and digitized film screen images must not be used for primary image interpretations" also suggests its role in image interpretation for diagnosis, as a warning about the types of images unsuitable for primary interpretation would only be relevant if the device were intended for that purpose with other images.
Yes
The device description explicitly states "Vision Tools is software that enables the user..." and describes its functions as software-based processing and integration with other systems. While it interacts with hardware (medical imaging machines, monitors), the device itself is presented as a software solution.
Based on the provided text, Millennium Technology's Vision Tools is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: IVD devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Vision Tools Function: Vision Tools is described as a medical imaging and information solution for radiology. Its primary function is to handle, process, and display medical images generated by imaging modalities like CT, MRI, and ultrasound. It also manages associated patient data.
- Lack of Specimen Analysis: The description does not mention Vision Tools analyzing any biological specimens. Its input is image data from medical imaging machines, not samples from the body.
Therefore, Vision Tools falls under the category of medical imaging software and not an IVD device.
N/A
Intended Use / Indications for Use
Millennium Technology's Vision Tools is intended to be used as a complete medical imaging and information solution that helps users in the Radiology/Tele-Radiology fields. It is considered one of the most powerful radiology viewing stations for PACS systems. Vision Tools is software that enables the user to handle all patient data including images, cine loops, reports, voice notes and information through the medical imaging machines that are connected to the system. It can handle all types of modalities (CT, MRI, US, CR, ...) and has many processing tools and functions such as handling DICOM work lists, integrating with PACS, RIS, HIS, speech recognition systems, DICOM printing, CD publishing, etc.
Product codes
LLZ
Device Description
Millennium Technology's Vision Tools is software that enables the user to handle all patient data including images, cine loops, reports, voice notes and information through the medical imaging machines that are connected to the system. It can handle all types of modalities (CT, MRI, US, CR, ...) and has many processing tools and functions such as handling DICOM work lists, integrating with PACS, RIS, HIS, speech recognition systems, DICOM printing, CD publishing, etc. With Vision Tools 3Dview, high quality 3D volumes from CT, MRI and ultrasound can be created with volume rendering, MPR, MIP, color rendering, cut planes, volume rotation and much more. The large number of image processing tools, filters, annotations, measurements, windowing and display functions can be customized for viewing. Lossy compressed mammogrphic images and digitized film screen images must not be used for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 Mpixel resolution and meets other technical specifications reviewed and accepted by the FDA.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT, MRI, US (Ultrasound), CR (Computed Radiography)
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Radiology/Tele-Radiology fields
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
§ 892.2050 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
Image /page/0/Picture/1 description: The image shows a logo for the Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES" written around the perimeter. Inside the circle is an abstract image of an eagle. The eagle is drawn with simple, stylized lines.
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
Ms. Christine Nichols Official Correspondent MTD, Inc. 8 Crownview Court SPARTA NJ 07871
Re: K063439
Trade/Device Name: Millennium Technology Vision Tools Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: November 8, 2006 Received: November 16, 2006
Dear Ms. Nichols:
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 (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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Image /page/0/Picture/10 description: The image shows a circular logo with the text "1906-2006" at the top. Below that, the letters "FDA" are prominently displayed. The word "Centennial" is written below the letters. Three stars are arranged in a row beneath the word "Centennial". The text at the bottom of the logo is difficult to read due to the image quality.
Protecting and Promoting Public Health
1
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 fimited to: registration and fisting (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.
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 this letter:
| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
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 from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150
or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html.
Sincerely yours,
Nancy C. Hogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known):
Device Name: Millennium Technology Vision Tools
Indications For Use:
Millennium Technology's Vision Tools is intended to be used as a complete medical imaging and information solution that helps users in the Radiology/Tele-Radiology fields. It is considered one of the most powerful radiology viewing stations for PACS systems. Vision Tools is software that enables the user to handle all patient data including images, cine loops, reports, voice notes and information through the medical imaging machines that are connected to the system. It can handle all types of modalities (CT, MRI, US, CR, ...) and has many processing tools and functions such as handling DICOM work lists, integrating with PACS, RIS, HIS, speech recognition systems, DICOM printing, CD publishing, etc.
With Vision Tools 3Dview, high quality 3D volumes from CT, MRI and ultrasound can be created with volume rendering, MPR, MIP, color rendering, cut planes, volume rotation and much more. The large number of image processing tools, filters, annotations, measurements, windowing and display functions can be customized for viewing. Lossy compressed mammogrphic images and digitized film screen images must not be used for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 Mpixel resolution and meets other technical specifications reviewed and accepted by the FDA,
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
David Ingram
(Division Sian-Off) Division of Reproductive. Abdominal, and