# K110332: Clearcanvas Ris / Pacs

- Pathway: 510(k) (Traditional)
- Applicant: Clearcanvas, Inc.
- Decided: Mar 24, 2011 after 49 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K010259 (2001). 8 ancestors in all.
4 later devices descend from it; 3 cite it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070080: Intelepacs, Intelerad Medical Systems, Inc. (2007) Summary page 1.

## Cited in the summary but kept off the family tree
- K081856: Brit Pacs Systems. Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K191530: StoneChecker (2019), 1 descendant of its own
- K213660: RadAlly (2023), 0 descendants of its own
- K202084: DeepLook PRECISE (2021), 0 descendants of its own
- K181460: OnePacs System (2018), 0 descendants of its own

## Recalls of this device
- Feb 26, 2020 · Class II · Z-1758-2020: A software defect negatively affects the quality of images taken during diagnostic imaging (mammograms) which may result in misdiagnosis.

## Indications for use
The ClearCanvas RIS/PACS is an image management system whose intended use is to provide scaleable DICOM compatible PACS solutions for hospitals and related institutions and sites, which will archive, distribute, retrieve and display images and data from all hospital modalities (such as CR, CT, DR, MR, and other devices) and information systems. This also includes the display of structured reports and mammography images that have been created according to DICOM "For Presentation", and will include standard features and other tools for analyzing mammography images. Lossy compressed mammography images and digitized film screen images must not be used for primary image interpretations. Mammography images may only be interpreted using an FDA approved monitor that offers at least 5 mega-pixel resolution and meets other technical specifications approved by the FDA.

Source page: https://510kreport.com/device/K110332
Methodology: https://510kreport.com/methodology