# K992751: Somavision

- Pathway: 510(k) (Traditional)
- Applicant: Varian Assoc., Inc.
- Decided: Feb 16, 2000 after 184 days
- Product code: KPQ (System, Simulation, Radiation Therapy)
- Device class: 2
- Regulation: 21 CFR 892.5840
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
310 later devices descend from it; 2 cite it directly.
1 of 311 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) General Electric Advantage Sim: named in the summary without a submission number

## Most influential descendants
- K013531: Qwiksim Virtual Simulation System; Version 2.00 (2001), 307 descendants of its own
- K061006: Ikoengelo (2006), 299 descendants of its own
- K071964: Mim 4.1 (Seastar) (2007), 287 descendants of its own
- K071950: Syngo Trued (2007), 201 descendants of its own
- K091373: Syngo Trued (2009), 200 descendants of its own

## Indications for use
Somavision is an advanced treatment planning preparation workstation for the physician and include high quality 3-D image capabilities. As part of the Varis Vision System, Somavision integrates treatment palnning in the overall therapy process, while taking advantage of the Varian Viston database.

Source page: https://510kreport.com/device/K992751
Methodology: https://510kreport.com/methodology