# K260500: ResolutionMD

- Pathway: 510(k) (Traditional)
- Applicant: ResolutionMD, Inc.
- Decided: Jul 21, 2026 after 158 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: 12 generations back to K954874 (1996). 53 ancestors in all.
No later device cites it as a predicate yet.
0 of 54 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K161130: ResolutionMD, Calgary Scientific, Inc. (2016) Summary page 5.

## Indications for use
The ResolutionMD solution is an enterprise imaging viewer that is used for the secure display, multiplanar reformatting and 3D visualization of medical image data and reports. It also provides for mobile access and real-time collaboration of clinical information. The software is intended for use as a review and analysis tool by authorized healthcare professionals to drive clinical management. When interpreted by a 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 displays both lossless and lossy compressed images. For lossy images, the healthcare professional must determine if the level of loss is acceptable for their purposes. Display monitors or mobile devices used for reading medical images for diagnostic purposes must comply with applicable regulatory clearances, technical specifications, and quality control requirements for their use and maintenance. For mammography, mobile devices do not comply with the minimum display requirements; therefore mobile device usage for mammography is for reference and referral only. Healthcare institutions may want to provide patients access to their clinical information. This access is for non-diagnostic informational purposes only.

Source page: https://510kreport.com/device/K260500
Methodology: https://510kreport.com/methodology