# K063439: Medical Image Management Devices for Vision Tools

- Pathway: 510(k) (Traditional)
- Applicant: Mtd, Inc.
- Decided: Jan 22, 2007 after 70 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## 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.

Source page: https://510kreport.com/device/K063439
Methodology: https://510kreport.com/methodology