# K081218: Bellystep, Headstep, Breaststep, Prostep, Wingstep and Icast

- Pathway: 510(k) (Traditional)
- Applicant: It-V Medizintechnik, GmbH
- Decided: Jul 21, 2008 after 82 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: 1 generation back to K991319 (1999). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K991319: Raycast Immobilization Systems Hardware and Thermoplastic Materials, Orfit Industries (1999) Summary page 12.

## Cited in the summary but kept off the family tree
- K060131: Oss-Bodies Proximal Tibial Sleeve, Biomet Manufacturing Corp (2006). Our reading of the summary gave K060131, FDA’s number for Oss-Bodies Proximal Tibial Sleeve (Biomet Manufacturing Corp). Its FDA name has none of the distinctive words the summary uses for the device it names, “SINMED Bellyboard System”. Kept off the family tree. Summary page 2.

## Indications for use
The function of the BellySTEP is for positioning of the lower abdomen of a patient during radiotherapy and diagnostics. The function of the HeadSTEP is for fixation and (re)positioning of the head- and neck area of the patient during radiotherapy and diagnostics. The function of the BreastSTEP is for positioning of the lung- and thorax area of the patient during radiotherapy and diagnostics. The function of the ProSTEP is for positioning of hip and lower extremities of a patient for radiotherapy. The function of the WingSTEP is for positioning of the lung- and thorax area of the patient during radiotherapy and diagnostics. The function of the iCAST thermoplastic materials are for use in retaining and reproducing a patient's position during radiation therapy.

Source page: https://510kreport.com/device/K081218
Methodology: https://510kreport.com/methodology