# K994231: Siemens Integrated Operating System (Sios)

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Corp.
- Decided: Aug 10, 2000 after 238 days
- Product code: ODA (Endoscopic Central Control Unit)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K801623 (1980). 24 ancestors in all.
157 later devices descend from it; 2 cite it directly.
4 of 182 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K981993: Olympus Integrated Endosurgery System Endoalpha, The Olympus Optical Co. (1998) Summary page 4.

## Cited in the summary but kept off the family tree
- K081798: EndoALPHA Integrated Endosurgery System. Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K052202: Axiom Artis - Modular Angiographic System (2006), 154 descendants of its own
- K061054: Axiom Aristos FX Plus (2006), 80 descendants of its own
- K062623: Axiom Luminos DRF (2007), 78 descendants of its own
- K073290: Artis Zee and Zeego (2008), 72 descendants of its own
- K090745: Artis Zee / Zeegos with SW VC14 (2009), 69 descendants of its own

## Indications for use
The SIOS product is intended to optimize procedures in the operating room by providing consistent pre-operative, intra-operative and post-operative equipment control, image and data handling, and networking capabilities, The SIOS product is limited to use with the following products: (1) Wolf Endocam - 3CCD Endocam 5507, (2) Wolf Light Source - Auto-CP 5131, (3) Wolf Insufflator - Laparo CO₂ Patu 2332, and (4) Maquet OR Table - ALPHAMAQUET 1150.

Source page: https://510kreport.com/device/K994231
Methodology: https://510kreport.com/methodology