# K011447: IN Space 3D

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Aug 3, 2001 after 84 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: 3 generations back to K954355 (1995). 6 ancestors in all.
244 later devices descend from it; 5 cite it directly.
1 of 251 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K984634: 3D-Angio, Siemens Medical Corp. (1999) Summary page 5.
- K003266: Siremobil Iso-C 3D, Siemens Medical Solutions USA, Inc. (2000) Summary page 1.
- K983877: Philips Integris 3D RA Option, Philips Medical Systems North America, Inc. (1998) Summary page 1.

## Most influential descendants
- 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
- K073003: Syngo Dual Energy with Extended Functionally (2008), 168 descendants of its own

## Indications for use
The In Space 3D 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 In Space 3D package is intended for imaging both hard and soft tissues as well as other internal body structures(eg. Lesions, Stent implants) for diagnosis, surgical planning, interventional procedures and treatment follow-up. As with the FDA cleared 3D Angio software package(K984634), this software package will also assist the physician in diagnosis and treatment of vessel malformations(i.e. Aneurysms, AVMs and Stenoses).

Source page: https://510kreport.com/device/K011447
Methodology: https://510kreport.com/methodology