# K963093: Siremobil Compact

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Sep 3, 1996 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: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K910115 (1991). 4 ancestors in all.
23 later devices descend from it; 2 cite it directly.
0 of 28 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K913525: Mobile X-Ray System, Siemens Medical Solutions USA, Inc. (1991) Summary page 3.
- K910902: VMX Mobile X-Ray System, GE Medical Systems (1991) Summary page 3.
- K910115: Philips BV-29 Imaging System, Philips Medical Systems, Inc. (1991) Summary page 3.
- K926056: 9600 Fluoroscopic Imaging System, Oec-Diasonics, Inc. (1993) Summary page 3.

## Most influential descendants
- K040066: Siremobile C06 (2004), 21 descendants of its own
- K051133: Arcadis Avantic (2005), 20 descendants of its own
- K132094: Cios Alpha (2014), 19 descendants of its own
- K153244: Cios Fusion (2016), 15 descendants of its own
- K181550: Cios Spin (2018), 10 descendants of its own

## Recalls of this device
- Aug 1, 2005 · Not classified · Z-0120-06: Screws may become loose and fall into the OR field during surgery.
- Aug 1, 2005 · Not classified · Z-0121-06: Screws may become loose and fall into the OR field during surgery.

## Indications for use
The Siremobil Compact is a mobile x-ray system intended for use in Operating room, Traumatology, Endoscopy, Intensive Care Station, Pediatrics, Ambulatory patient care and in Veterinary Medicine. The Siremobil Compact can operate in four different modes, Digital Radiography, Fluoroscopy and pulsed Fluoroscopy and Cassette exposure which are necessary in performing wide variety of clinical procedures, such as intraoperative bile duct display, fluoroscopic display of intra-medullary nail implant in various positions, low dose fluoroscopy in pediatrics, fluoroscopic techniques utilized in pain therapy and positioning of catheters and probes.

Source page: https://510kreport.com/device/K963093
Methodology: https://510kreport.com/methodology