# K001643: Varis 1.4G

- Pathway: 510(k) (Special)
- Applicant: Varian Medical Systems, Inc.
- Decided: Jun 23, 2000 after 24 days
- Product code: IYE (Accelerator, Linear, Medical)
- Device class: 2
- Regulation: 21 CFR 892.5050
- Recalls of this device: 8 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
183 later devices descend from it; 2 cite it directly.
0 of 184 devices 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.

## Most influential descendants
- K042956: Vision (2005), 121 descendants of its own
- K112930: Mobile Mim (2011), 99 descendants of its own
- K050479: 4D Integrated Treatment Console (2005), 72 descendants of its own
- K081036: 4D Integrated Treatment Console with Patient Accessory Verification System (Pavs) (2008), 69 descendants of its own
- K151913: MIM-Thin Client (mobile) (2016), 68 descendants of its own

## Recalls of this device
- Feb 7, 2011 · Not classified · Z-1957-2011: An issue with the Varis Vision software where treatment can occur without the dynamic Multileaf Collimator component and may deliver a higher than expected dose of radiation.
- Sep 15, 2009 · Not classified · Z-0133-2010: Software issue: Under certain circumstances, when a therapy treatment field is transferred to VARiS Vision 6.2, 6.1 and 6.0 via LINK procedures, the rotation direction will be reversed.
- May 8, 2009 · Not classified · Z-1809-2009: Potential mistreatment-- due to software issues, retired plans may be used and treated repeatedly.
- Jun 2, 2008 · Not classified · Z-0164-2009: A malfunction within the Varis software might result in a misadministration (underdose). The software does not correctly interpret the number, causing field parameters having decimal values to be inco
- May 21, 2008 · Not classified · Z-2194-2008: Dose delivery may be altered after import from a third party planning system during radiation therapy.
- Oct 2, 2007 · Not classified · Z-0720-2008: Incorrect Software Validation- The ARC treatment plans containing a Dose Dynamic MLC for IMRT delivery that will not be recognized properly by the system. Under these circumstances, an arc plan can be
- Sep 21, 2006 · Not classified · Z-0304-2007: Selecting an empty space next to the ''Override'' or ''Acquire Actual'' buttons may result in mistreatment to the patient.
- Jan 31, 2003 · Not classified · Z-0633-03: The product has a software problem. This could result in a treatment without a motorized wedge where one had been planned.

Source page: https://510kreport.com/device/K001643
Methodology: https://510kreport.com/methodology