# K161130: ResolutionMD

- Pathway: 510(k) (Traditional)
- Applicant: Calgary Scientific, Inc.
- Decided: Aug 24, 2016 after 125 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: 11 generations back to K954874 (1996). 52 ancestors in all.
4 later devices descend from it; 4 cite it directly.
0 of 57 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133508: Resolutionmd Mobile, Calgary Scientific, Inc. (2014) Summary page 5.
- K120076: Resolutionmd Web, Calgary Scientific, Inc. (2012) Summary page 5.

## Most influential descendants
- K260500: ResolutionMD (2026), 0 descendants of its own
- K183248: Synapse Enterprise Viewer Version 1.0 (2019), 0 descendants of its own
- K181185: Change Healthcare Enterprise Viewer (2018), 0 descendants of its own
- K162655: StealthConnect Remote Viewing, Planning and Collaboration System (2017), 0 descendants of its own

## Indications for use
ResolutionMD® software is an enterprise medical image viewer used with off-the-shelf servers, web browsers, and specific mobile devices for the 2D display, Multi-planar reformatting and 3D visualization of medical image data and reports. It provides collaboration and integrated secure audio-video communication, and displays DICOM and non-DICOM medical images and reports. ResolutionMD is intended for use as a diagnostic, review, and analysis tool by trained healthcare professionals to drive clinical management. When interpreted by a trained physician, reviewed images may be used to aid in diagnosis. When used on a mobile device, ResolutionMD is not intended to replace full radiology workstations. ResolutionMD is not to be used for primary mammography diagnoses. ResolutionMD® software is an enterprise medical image viewer used with off-the-shelf servers, web browsers, and specific mobile devices for the 2D display, Multi-planar reformatting and 3D visualization of medical image data and reports. It provides collaboration and integrated secure audio-video communication, and displays DICOM and non-DICOM medical images and reports. ResolutionMD incorporates a Vessel Analysis module which is used as a post-processing diagnostic review and analysis application for images viewed from ResolutionMD. It is a tool for use by trained healthcare professionals to review, edit, analyze and report findings of vascular anatomy. Clinicians can semi-automatically determine contrasted lumen boundaries and stenosis measurements, and evaluate maximum and minimum lumen diameters and length measurements. ResolutionMD is intended for use as a diagnostic, review, and analysis tool by trained healthcare professionals to drive clinical management. When interpreted by a trained physician, reviewed images may be used to aid in diagnosis. When used on a mobile device, ResolutionMD is not intended to replace full radiology workstations. ResolutionMD is not to be used for primary mammography diagnoses.

Source page: https://510kreport.com/device/K161130
Methodology: https://510kreport.com/methodology