# K133508: Resolutionmd Mobile

- Pathway: 510(k) (Traditional)
- Applicant: Calgary Scientific, Inc.
- Decided: Mar 26, 2014 after 132 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: 10 generations back to K954874 (1996). 50 ancestors in all.
5 later devices descend from it; 1 cites it directly.
0 of 56 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123186: Resolutionmd Mobile 3.1 Model RMD-Mob-31, Calgary Scientific, Inc. (2013) Summary page 1.
- K111346: Resolutionmd Mobile Model RMB-Mob-2X, Calgary Scientific, Inc. (2011) Summary page 1.
- K112930: Mobile Mim, Mim Software, Inc. (2011) Summary page 1.
- K110875: Centricity Pacs, GE Healthcare (2011) Summary page 1.

## 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
ResolutionMDM Mobile is a software-based Picture Archiving and Communication System (PACS) used with general purpose computing servers and specific mobile devices. It provides for communication, storage, reformatting, rendering on the server component and communication and display of DICOM 3.0-compliant medical images as well as reports on the mobile device. ResolutionMD Mobile provides wireless and portable access to medical images. The device is intended for use as a diagnostic, review, and analysis tool by trained professionals such as radiologists, physicians and technologists. This device is not intended to replace full workstations and should be used only when there is no access to a workstation. ResolutionMD Mobile is not to be used for mammography.

Source page: https://510kreport.com/device/K133508
Methodology: https://510kreport.com/methodology