# K932501: Varian Origami, Version 1.0

- Pathway: 510(k) (Traditional)
- Applicant: Varian Assoc., Inc.
- Decided: Sep 23, 1994 after 486 days
- Product code: IYE (Accelerator, Linear, Medical)
- Device class: 2
- Regulation: 21 CFR 892.5050
- 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.
No later device cites it as a predicate yet.
0 of 1 device 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.

## Recalls of this device
- May 13, 2010 · Not classified · Z-0455-2011: Incorrect treatment plan or record: A software design deficiency has the potential for corrupted treatment plan records or treatment records in cases where multiple users editing a record simultaneous
- Nov 23, 2005 · Not classified · Z-0393-06: The export of multi-static segment BrainLab M 3 MLC from VARiS Vision may produce undesirable result, which could lead to mistreatment.

Source page: https://510kreport.com/device/K932501
Methodology: https://510kreport.com/methodology