# K974715: Advantage 3D XR

- Pathway: 510(k) (Traditional)
- Applicant: GE Medical Systems
- Decided: Jul 6, 1998 after 201 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
Longest line of descent: 1 generation back to K954355 (1995). 1 ancestor in all.
298 later devices descend from it; 2 cite it directly.
1 of 300 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K954355: Advantage Windows 3D with Navigator Option, General Electric Co. (1995) Summary page 1.

## Most influential descendants
- K984634: 3D-Angio (1999), 245 descendants of its own
- K011447: IN Space 3D (2001), 244 descendants of its own
- K043469: Syngo Inspace 4D (2005), 218 descendants of its own
- K071513: Inspace 4D Software Package with Extended Functionality (2007), 210 descendants of its own
- K062673: Modification to Syngo Inspace 4D (2006), 172 descendants of its own

## Indications for use
The Advantage 3D XR is an X-ray imaging software option that offers the ability to construct a 3D model from images taken during a single DSA rotational angiography. The product is optimized for neuro-angiographic cases.

Source page: https://510kreport.com/device/K974715
Methodology: https://510kreport.com/methodology