# K051602: Axiom Sireskop SD

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Systems, Inc.
- Decided: Jul 7, 2005 after 21 days
- Product code: JAA (System, X-Ray, Fluoroscopic, Image-Intensified)
- Device class: 2
- Regulation: 21 CFR 892.1650
- Recalls of this device: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K912470 (1991). 7 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K951358: Sireskop SX, Siemens Medical Solutions USA, Inc. (1995) Summary page 2.
- K992660: Urf Digital - OT, Siemens Medical Solutions USA, Inc. (1999) Summary page 2.

## Most influential descendants
- K111292: Luminos Agile (2011), 2 descendants of its own
- K173639: Luminos dRF Max, Luminos Agile Max, Uroskop Omnia Max, Multitom Rax (2018), 1 descendant of its own
- K250660: LUMINOS Q.namix T; LUMINOS Q.namix R (2025), 0 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 14, 2011 · Not classified · Z-1421-2011: Firm became aware of a potential malfunction and possible hazard to patients in the event the tilt buttons on the OPTI Grip become stuck under the housing
- Jul 13, 2010 · Not classified · Z-2222-2010: Fluid may enter the multi-functional handle (Opti Grip) when using the Axiom Luminos TF or Sireskop SD system, causing unintended reaction or movement, increased radiation or useless images.
- Jan 8, 2009 · Not classified · Z-1254-2009: During interventional use and applications, the possibility exists for liquids to enter the systems.
- Aug 12, 2008 · Not classified · Z-0101-2009: Liquids may enter the system and cause potential malfunction and possible hazard to patients, user or other persons.

## Indications for use
The AXIOM Sireskop SD is intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic studies. Using either film cassettes or a digital mobile flat detector, it can perform a range of applications including general R/F, angiography and pediatric examinations. AXIOM Sireskop SD may be used for emergency treatment on an outpatient basis, as well as for bedside examinations.

Source page: https://510kreport.com/device/K051602
Methodology: https://510kreport.com/methodology