# K032280: Siremobil Iso-C 3D

- Pathway: 510(k) (Abbreviated)
- Applicant: Siemens AG
- Decided: Sep 10, 2003 after 48 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 K003266 (2000). 3 ancestors in all.
83 later devices descend from it; 3 cite it directly.
2 of 87 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003266: Siremobil Iso-C 3D, Siemens Medical Solutions USA, Inc. (2000)
- K003837: Flexiview 8800 Digital Mobile Imaging System, Ge Oec Medical Systems (2001)
- K010435: Philips BV Pulsera/Endura, Philips Medical Systems, Inc. (2001)

## Most influential descendants
- K050996: O-Arm Imaging System (2005), 52 descendants of its own
- K060344: O-Arm Imaging System (2006), 51 descendants of its own
- K081672: C-Insight (2008), 33 descendants of its own
- K102130: Tenzing System (2010), 31 descendants of its own
- K061310: Ziehm Vario 3D Digital Mobile Imaging System (2006), 29 descendants of its own

## Indications for use
The Siremobil Iso-C 3D with extended Indications for Use is based on Siemens isocentric mobile C-arm, marketed as Siremobil Iso-C 3D. The extended Indications for Use to include the entire spine for the Siremobil Iso-C 3D contains no new hardware or software The Siremobil Iso-C 3D 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 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 entire spine.

Source page: https://510kreport.com/device/K032280
Methodology: https://510kreport.com/methodology