# K113548: Pedcat

- Pathway: 510(k) (Traditional)
- Applicant: Curvebeam, LLC
- Decided: Apr 10, 2012 after 131 days
- Product code: JAK (System, X-Ray, Tomography, Computed)
- Device class: 2
- Regulation: 21 CFR 892.1750
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
4 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K080098: MRJ Extended, Paramed S.R.L. (2008). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K180727: LineUp (2018), 2 descendants of its own
- K203187: HiRise (2020), 1 descendant of its own
- K241713: HiRise (1040-230) (2024), 0 descendants of its own
- K170789: In Reach (2017), 0 descendants of its own

## Indications for use
The PedCAT is intended to be used for 3-D imaging of the foot & ankle region, to visualize and assess the osseous and certain soft tissue structures, including joint spaces, bone angles and fractures. This modality is anticipated to be applicable to pediatric* cases as well as adults*, when appropriate diagnosis of a given foot condition is considered necessary. *Patient parameters: 50 lbs to 400 lbs Groin area at least 22" above the floor

Source page: https://510kreport.com/device/K113548
Methodology: https://510kreport.com/methodology