# K062164: Resolutionmd, Version 1.3

- Pathway: 510(k) (Traditional)
- Applicant: Calgary Scientific, Inc.
- Decided: Sep 22, 2006 after 56 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
Longest line of descent: 5 generations back to K913770 (1991). 20 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050033: Lucion, Mevisys Co., Ltd. (2005) Summary page 1.
- K992654: Plug 'N View 3D, Version 1.0, Voxar Limited (1999) Summary page 1.
- K032748: VITREA2, Version 3.4 Medical Image Processing Software, Vital Images, Inc. (2003) Summary page 1.

## Most influential descendants
- K100236: Stair Systems Pacs & Dicom Viewer (2010), 1 descendant of its own
- K112008: Touchpacs Suite (2012), 0 descendants of its own

## Indications for use
ResolutionMDTM is a software based Picture Archiving and Communication System (PACS) used with general purpose computing hardware for the display and 3D visualization of medical image data. It provides for communication, storage, processing, rendering, and display of DICOM 3.0 compliant image data derived from various sources including CT and MRI. ResolutionMDTM is intended for use as a diagnostic, review, and analysis tool by trained professionals such as physicians, technologists, and nurses. When interpreted by a trained physician, reviewed images may be used as an element for diagnosis. It is the user's responsibility to ensure that the software is installed on appropriate hardware and that image quality is suitable for the clinical application. Lossy compressed mammographic images and digitized film screen images must not be reviewed 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 FDA.

Source page: https://510kreport.com/device/K062164
Methodology: https://510kreport.com/methodology