# K010942: U04

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Apr 12, 2001 after 14 days
- Product code: OWB (Interventional Fluoroscopic X-Ray System)
- 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.
12 later devices descend from it; 1 cites it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K101491: Uroskop Omnia (2010), 11 descendants of its own
- K122768: Genesis (2013), 4 descendants of its own
- K161019: Uroview FD (2016), 2 descendants of its own
- K133434: Genesis II (2014), 2 descendants of its own
- K173639: Luminos dRF Max, Luminos Agile Max, Uroskop Omnia Max, Multitom Rax (2018), 1 descendant of its own

## Recalls of this device
- Apr 30, 2012 · Class II · Z-2341-2012: Siemens has discovered a possible hazard to patients or hospital personnel when tilting the Uroskop Access system starting with serial number 6076. When tilting the table on the Uroskop Access table, 

Source page: https://510kreport.com/device/K010942
Methodology: https://510kreport.com/methodology