# K933227: Uni-Frame Head Immobilization System

- Pathway: 510(k) (Traditional)
- Applicant: Medtec, Inc.
- Decided: Jul 18, 1994 after 381 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.
22 later devices descend from it; 4 cite it directly.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K030051: Versaboard, Model 7040 (2003), 18 descendants of its own
- K060737: Sinmed Positioning Devices (2006), 17 descendants of its own
- K080072: Mri Patient Positioning Devices (2008), 15 descendants of its own
- K093738: Mri Patient Positioning Devices (2010), 14 descendants of its own
- K111340: Head and Neck Immobilization System, Body Immobilization System (2011), 13 descendants of its own

## Recalls of this device
- May 12, 2020 · Class II · Z-2243-2020: Potential for disengagement of the Varian Style Type-S Extension during patient repositioning. The risk associated with the disengagement of the extension could be a patient fall if the patient is not
- Aug 31, 2009 · Not classified · Z-0124-2010: Some of the packages contain the incorrect mask style.

Source page: https://510kreport.com/device/K933227
Methodology: https://510kreport.com/methodology