# K960266: Siregraph CF

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Mar 11, 1996 after 53 days
- Product code: JAA (System, X-Ray, Fluoroscopic, Image-Intensified)
- Device class: 2
- Regulation: 21 CFR 892.1650
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K912470 (1991). 3 ancestors in all.
132 later devices descend from it; 1 cites it directly.
0 of 136 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.
- K924310: Prestilix 1694 D Image Intensified Fluorosccopic, GE Medical Systems (1993) Summary page 2.
- K912470: Philips Diagnost 96, Philips Medical Systems, Inc. (1991) Summary page 2.

## Most influential descendants
- 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
- K081722: YSIO (2008), 43 descendants of its own

## Recalls of this device
- Sep 23, 2009 · Not classified · Z-0189-2010: possible injury to hand/fingers
- Jun 7, 2004 · Not classified · Z-1475-04: X-ray tube movement when table is tilted more than 90 degrees
- Jun 7, 2004 · Not classified · Z-1476-04: X-ray tube movement when table is tilted more than 90 degrees

## Indications for use
The Siemens Siregraph CF is a remote overtable radiographic/fluoroscopic x-ray diagnostic system that was designed for universal implementation in the hospital and clinical environment. The Siregraph CF, remote X-ray system, has medical applications ranging from gastrointestinal examinations to cranial, skeletal, thoraic and lung exposures as well as examinations of the urinary tract, lymphography, myelography, venography, arthrography angiography and DSA.

Source page: https://510kreport.com/device/K960266
Methodology: https://510kreport.com/methodology