# K951358: Sireskop SX

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: May 15, 1995 after 52 days
- Product code: JAA (System, X-Ray, Fluoroscopic, Image-Intensified)
- 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
No predicates in its family tree.
133 later devices descend from it; 2 cite it directly.
0 of 134 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
- K960266: Siregraph CF (1996), 132 descendants of its own
- K970734: Siregragh T.O.P. 33 and Siregraph T.O.P. 40 Universal Fluoroscopic X-Ray Systems (1997), 131 descendants of its own
- K992660: Urf Digital - OT (1999), 130 descendants of its own
- K062623: Axiom Luminos DRF (2007), 78 descendants of its own
- K040675: Axiom Artis U (2004), 49 descendants of its own

## Recalls of this device
- 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
- Jan 8, 2009 · Not classified · Z-1253-2009: During interventional use and applications, the possibility exists for liquids to enter the systems.

Source page: https://510kreport.com/device/K951358
Methodology: https://510kreport.com/methodology