# K120076: Resolutionmd Web

- Pathway: 510(k) (Traditional)
- Applicant: Calgary Scientific, Inc.
- Decided: Apr 19, 2012 after 100 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.
5 later devices descend from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K161130: ResolutionMD (2016), 4 descendants of its own
- 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
The ResolutionMD(TM) isa 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, reformatting, rendering, and display of DICOM 3.0 compliant image data derived from various sources including CT and MRI. The ResolutionlMD software is intended for use as adiagnostic, 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 isthe user's responsibility to ensure that the software is installed on appropriate hardware and that *image quality issuitable for the clinical application. Calgary Scientific recommends that users of the ResolutionMVD software consult the appropriate American College of Radiology Practice Guidelines pertaining to the anatomy and pathology being studied. *ResolutionMVD Web 2.9 is not to be used for mammography. The ResolutionMD(TM) isa 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, reformatting, rendering, and display of DICOM 3.0 compliant image data derived from various sources including CT and MRI. The ResolutionMVD device incorporates a Calcium Scoring module which isused to identify and quantify calcified plaque within the coronary arteries. This protocol isperformed on non-contrast enhanced cardiac CT data sets. The ResolutionMD software isintended 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 isthe user's responsibility to ensure that the software isinstalled on appropriate hardware and that image quality is suitable for the clinical application. Calgary Scientific recommends that users of the ResolutionMD software consult the appropriate American College of Radiology Practice Guidelines pertaining to the anatomy and pathology being studied. ResolutionlMO Web 2.9 isnot to be used for mammography. The Resolution MD(TM) isa 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, reformatting, rendering, and display of DICOM 3.0 compliant image data derived from various sources including CT and MRI. The ResolutionIVI device incorporates a Coronary Analysis protocol which isused to visually identify and measure stenoses in the coronary arteries. This protocol isperformed on contrast-enhanced cardiac CTA data sets. The Resolution!MD software 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 isthe user's responsibility to ensure that the software isinstalled on appropriate hardware and that image quality issuitable for the clinical application. Calgary Scientific recommends that users of the ResolutionMD software consult the appropriate American College of Radiology Practice Guidelines pertaining to the anatomy and pathology being studied. ResolutionMOI Web 2.9 isnot to be used for mammography. ResolutionMD TMWeb 2.9 isa 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, reformatting, rendering, and display of DICOM 3.0 compliant image data derived from various sources including CT and MRI. ResolutionMD Web 2.9 incorporates a Vessel Analysis module which is used as a post-processing diagnostic review and analysis application for images viewed from ResolutionMD T, a PACS workstation or DICOM image viewer. It is atool for use by trained professionals such as physicians, technologists and surgeons 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 Web 2.9 isintended for use as a diagnostic, review, and analysis tool by train ed professionals such as physicians, technologists, and nurses. When interpreted by a trained physician, reviewed images may be used as an element for diagnosis. It isthe user's responsibility to. ensure that the software isinstalled on appropriate hardware and that image quality issuitable for the clinical application. Calgary Scientific recommends that users of the ResolutionMD Web 2.9 consult the appropriate American College of Radiology Practice Guidelines pertaining to the anatomy and pathology being studied. ResolutionMD Web 2.9 isnot to be used for mammography.

Source page: https://510kreport.com/device/K120076
Methodology: https://510kreport.com/methodology