# K970734: Siregragh T.O.P. 33 and Siregraph T.O.P. 40 Universal Fluoroscopic X-Ray Systems

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Apr 21, 1997 after 52 days
- Product code: OWB (Interventional Fluoroscopic X-Ray System)
- Device class: 2
- Regulation: 21 CFR 892.1650
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K912470 (1991). 5 ancestors in all.
131 later devices descend from it; 1 cites 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)
- K860913: Siregraph D, Siemens Medical Solutions USA, Inc. (1986) Summary page 2.
- K960266: Siregraph CF, Siemens Medical Solutions USA, Inc. (1996) Summary page 2.

## Most influential descendants
- 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
- K121513: Multix Fusion (2012), 32 descendants of its own

## Indications for use
The Siregraph T.O.P. 33 and Siregraph T.O.P. 40 Universal Fluoroscopic X-ray Systems are devices intended to visualize anatomical structures by converting a pattern of X-ray into a visible image through electronic amplification. Both systems have medical applications ranging from gastrointestinal examinations to cranial, skeletal, thoracic and lung exposures as well as examination of the urogenital tract, lymphography, endoscopy, myelography, venography, pediatrics, arthrography, interventional radiology, digital angiography, and digital subtraction angiography (DSA).

Source page: https://510kreport.com/device/K970734
Methodology: https://510kreport.com/methodology