# K040347: Siremobil Iso-C 3D

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Systems, Inc.
- Decided: Mar 9, 2004 after 26 days
- Product code: OXO (Image-Intensified Fluoroscopic X-Ray System, Mobile)
- Device class: 2
- Regulation: 21 CFR 892.1650
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
70 later devices descend from it; 3 cite it directly.
0 of 71 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K032088: Modification to Thermacool TC System, Thermage, Inc. (2003). Our OCR of the scanned summary read K032088, FDA’s number for Modification to Thermacool TC System (Thermage, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “Siemens Siremobil Iso-C 3D”. Kept off the family tree. Summary page 1.

## Most influential descendants
- K081672: C-Insight (2008), 33 descendants of its own
- K102130: Tenzing System (2010), 31 descendants of its own
- K110911: Renaissance System (2011), 24 descendants of its own
- K113228: Renaissance System (2011), 23 descendants of its own
- K140167: Renaissance X System (2014), 21 descendants of its own

## Recalls of this device
- Aug 1, 2005 · Not classified · Z-0122-06: Screws may become loose and fall into the OR field during surgery.

## 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 include the high contrast objects and anatomical structures of the entire body. The Siremobil Iso-C 3D contains no new hardware or software. The Siremobil Iso-C 3D is designed as a 3D imaging device and is intended to be used whenever the physician benefits from intraoperatively generated 3D information of high contrast objects and anatomical structures.

Source page: https://510kreport.com/device/K040347
Methodology: https://510kreport.com/methodology