# K060737: Sinmed Positioning Devices

- Pathway: 510(k) (Traditional)
- Applicant: Sinmed BV
- Decided: Mar 31, 2006 after 11 days
- Product code: IYE (Accelerator, Linear, Medical)
- Device class: 2
- Regulation: 21 CFR 892.5050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K905007 (1991). 9 ancestors in all.
17 later devices descend from it; 4 cite it directly.
0 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K933613: 3-Way Head Immobilizer; 3WAY Deluxe Reusable Frame Head Immobilizer, Bionix Development Corp. (1993) Summary page 1.
- K030051: Versaboard, Model 7040, Bionix Development Corp. (2003) Summary page 3.
- K974703: Carbon Fiber Breast Board, Medtec, Inc. (1998) Summary page 5.
- K023293: Med-Tec Bellyboard, Models MT-Bba-01 & MT-Bba-02, Med-Tec,Inc. (2002) Summary page 7.
- K950866: Hip Fixation System, Medtec, Inc. (1995) Summary page 9.
- K935300: Vac-Lok Immobilization System, Medtec, Inc. (1994) Summary page 11.
- K926187: Posicast Immobilization System, Huestis Machine Corp. (1994) Summary page 13.

## Most influential descendants
- 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
- K142420: Patient Positioning Devices (2015), 7 descendants of its own
- K122888: CDR Systems Precision Patient Positioning System (2013), 5 descendants of its own
- K153026: Body Pro-Lok Respiratory Plate, Respiratory Plate Cushion, Body Pro-Respiratory Belt, Rail Clamp for Respiratory Belt, Pressure Gauge Replacement (2016), 3 descendants of its own

## Indications for use
Fixation and (re)positioning of the head- and neck area of the patient during radiotherapy and diagnostics. Fixation and (re~positioning of the head- and neck area of the patient during radiotherapy and diagnostics. Positioning of the lung- and thorax area of the patient during radiotherapy and diagnostics. Positioning of the lower abdomen of a patient during radiotherapy and diagnostics. Positioning of hip and lower extremities of a patient during radiotherapy and diagnostics. Fixation and (re~positioning of the patient during radiotherapy and diagnostics, Fixation and (re)positioning of the patient during radiotherapy and diagnostics.

Source page: https://510kreport.com/device/K060737
Methodology: https://510kreport.com/methodology