# K984634: 3D-Angio

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Corp.
- Decided: Mar 12, 1999 after 72 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: 2 generations back to K954355 (1995). 2 ancestors in all.
245 later devices descend from it; 1 cites it directly.
1 of 248 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K974715: Advantage 3D XR, GE Medical Systems (1998) Summary page 1.

## Most influential descendants
- 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
- K062351: Syngo Dual Energy (2006), 169 descendants of its own

## Indications for use
The 3D-Angio package is a x-ray imaging software option which allows the reconstruction of two-dimensional images acquired with a standard angiographic C-arm device into a three-dimensional image format. The 3D-Angio package is intended to assist the physician in diagnosis and treatment of vessel malformations (i.e. aneurysms, AVMs, stenoses), particularly neuro-angiographic cases.

Source page: https://510kreport.com/device/K984634
Methodology: https://510kreport.com/methodology