# K973270: Leg'map Option

- Pathway: 510(k) (Traditional)
- Applicant: Ge Medical Systems, Inc.
- Decided: Nov 25, 1997 after 84 days
- Product code: IZI (System, X-Ray, Angiographic)
- Device class: 2
- Regulation: 21 CFR 892.1600
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K031396: Advantage Workstation Pasting 1.1 (2003), 0 descendants of its own

## Indications for use
The Leg’Map software is intended for use to combine a series of digital images acquired by diagnostic radiography during a table translation into a single image, such as combining a series of images of the arteries of the lower leg acquired during bolus chasing. Leg’Map provides the convenience of viewing a single image rather than several images. Also, the Leg’Map digital image meets the preference of those who want an image similar to that of the long cut film (30cm x 120cm) previously used when performing this procedure.

Source page: https://510kreport.com/device/K973270
Methodology: https://510kreport.com/methodology