# K141364: Climb Mammography Viewer Software

- Pathway: 510(k) (Traditional)
- Applicant: Climb Medical Systems, Inc.
- Decided: Aug 29, 2014 after 98 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: 6 generations back to K904519 (1991). 18 ancestors in all.
No later device cites it as a predicate yet.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040468: Cedara I-Softview and Cedara I-Readmammo, Cedara Software Corp. (2004) Summary page 4.
- K073272: Workstationone Breast Imaging Workstation, Three Palm Software, LLC (2007) Summary page 4.

## Indications for use
Climb-Mammography Viewer is intended to be used by radiologists for the reading, manipulation and interpretation of DICOM digital breast images including mammography. Radiologists are able to select, display, manipulate, quantify, mark-up, print and exchange images. Lossy compressed mammographic images must not be reviewed for primary image interpretations. Images may only be interpreted using an FDA cleared display that meets technical specifications reviewed and accepted by FDA for digital mammography. All images must conform to regulatory requirements. Image quality must conform to applicable quality guidance.

Source page: https://510kreport.com/device/K141364
Methodology: https://510kreport.com/methodology