# K111346: Resolutionmd Mobile Model RMB-Mob-2X

- Pathway: 510(k) (Traditional)
- Applicant: Calgary Scientific, Inc.
- Decided: Sep 9, 2011 after 119 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.
7 later devices descend from it; 2 cite it directly.
0 of 8 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
- K123186: Resolutionmd Mobile 3.1 Model RMD-Mob-31 (2013), 6 descendants of its own
- K133508: Resolutionmd Mobile (2014), 5 descendants of its own
- 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

## Indications for use
The ResalutionMD' Mobile software isa 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 CT and MR medical images as well as reports on the mobile device. The ResolutionMO 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. The ResolutionMD Mobile is not to be used for mammography.

Source page: https://510kreport.com/device/K111346
Methodology: https://510kreport.com/methodology