# K992660: Urf Digital - OT

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Nov 5, 1999 after 88 days
- Product code: OWB (Interventional Fluoroscopic X-Ray System)
- Device class: 2
- Regulation: 21 CFR 892.1650
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K912470 (1991). 6 ancestors in all.
130 later devices descend from it; 3 cite it directly.
0 of 137 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K970734: Siregragh T.O.P. 33 and Siregraph T.O.P. 40 Universal Fluoroscopic X-Ray Systems, Siemens Medical Solutions USA, Inc. (1997) Summary page 1.

## Most influential descendants
- K062623: Axiom Luminos DRF (2007), 78 descendants of its own
- K040675: Axiom Artis U (2004), 49 descendants of its own
- K081722: YSIO (2008), 43 descendants of its own
- K121513: Multix Fusion (2012), 32 descendants of its own
- K133259: Ysio Max (2014), 23 descendants of its own

## Recalls of this device
- Dec 9, 2022 · Class II · Z-1000-2023: There is potential for the footrest to detach from the patient table during use.
- Jan 15, 2013 · Class II · Z-1097-2013: Siemens has become aware of a potential malfunction and possible hazard to patients and staff when using the Iconos R200 C20, Iconos R200 T20, Iconos R100, Iconos MD, Iconos RHD, Luminos RF Classic, L
- Jan 29, 2010 · Not classified · Z-1213-2010: table can tilt/move when it is not intended
- May 1, 2009 · Not classified · Z-1438-2009: Improper installation of accessory support arm, which could potentially result in the loosening of the arm over time causing it to fall.

## Indications for use
The Siemens URF Digital - OT is intended to visualize anatomical structures by converting a pattern of X-ray into a visible image through electronic amplification. The system has medical applications ranging from gastrointestinal examinations to cranial, skeletal, thoracic and lung exposures, as well as examination of the urogenital tract. The URF Digital - OT may also be used in lymphography, endoscopy, myelography, venography, pediatrics, arthrography, interventional radiology, digital angiography, and digital subtraction angiography (DSA).

Source page: https://510kreport.com/device/K992660
Methodology: https://510kreport.com/methodology