# K022337: 3D Navigation Interface for Siremobile Iso-C 3D

- Pathway: 510(k) (Special)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Aug 13, 2002 after 26 days
- Product code: IZL (System, X-Ray, Mobile)
- Device class: 2
- Regulation: 21 CFR 892.1720
- 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 K973598 (1997). 2 ancestors in all.
22 later devices descend from it; 1 cites it directly.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K973598: Siremobil CO2, Siemens Medical Solutions USA, Inc. (1997) Summary page 1.
- K003266: Siremobil Iso-C 3D, Siemens Medical Solutions USA, Inc. (2000) Summary page 2.

## Most influential descendants
- K042793: Arcadis Ordic (Available with Options 3D and 3D Navigation Interface) (2004), 21 descendants of its own
- K181550: Cios Spin (2018), 10 descendants of its own
- K202547: Surgivisio system (2021), 9 descendants of its own
- K203504: Cios Flow (2020), 9 descendants of its own
- K220627: SURGIVISIO Device (2022), 8 descendants of its own

## Indications for use
The Siremobil Iso-C 3D with the 3D Navigation Interface option is based on Siemens isocentric mobile C-arm, marketed as Siremobil Iso-C. The 3D imaging option of the Siremobil Iso-C 3D contains hardware for the motorized movement of the orbital axis, a 3D workstation and a software package for volume reconstruction from two-dimensional images, 3D post-processing and visualization. The Siremobil Iso-C 3D with the 3D Navigation Interface option is intended to be used whenever the surgeon benefits from intraoperatively generated 3D information of high contrast objects and anatomical structures (e.g. bones and joints). The Siremobil Iso-C 3D with the 3D Navigation Interface option is designed as a 3D imaging device for conditions such as complex bone or joint fractures of the upper and lower extremities (including knee, foot, elbow, hand), and the spine.

Source page: https://510kreport.com/device/K022337
Methodology: https://510kreport.com/methodology