# K091209: Portalvision Advanced Imaging

- Pathway: 510(k) (Traditional)
- Applicant: Varian Medical Systems, Inc.
- Decided: Jun 23, 2009 after 60 days
- Product code: IYE (Accelerator, Linear, Medical)
- Device class: 2
- Regulation: 21 CFR 892.5050
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K901932 (1991). 3 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003636: Portalvision, Varian Medical Systems, Inc. (2001) Summary page 1.
- K971839: Varian Radiation Therapy Imaging System, Varian Medical Systems, Inc. (1997) Summary page 1.

## Most influential descendants
- K200940: BeamSite (2020), 1 descendant of its own
- K212606: BeamSite (2021), 0 descendants of its own

## Recalls of this device
- Nov 23, 2011 · Not classified · Z-0516-2012: An anomaly was discovered when using the 4DITC in combination with an R-Arm to acquire double exposure MV images.

## Indications for use
The PortalVision Advanced Imaging device is used to acquire images of anatomical landmarks, fiducial markers, the shape of the treatment beam and dosimetric signals to guide the delivery of radiation anywhere in the body where radiation treatment is indicated.

Source page: https://510kreport.com/device/K091209
Methodology: https://510kreport.com/methodology