BellySTEP, HeadSTEP, BreastSTEP, ProSTEP, WingSTEP, and ICAST
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K081218 FDA 510(k)
- FDA Product Code
- IYE FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.5050 FDA 510(k)
- Regulation Number
- 892.5050 FDA 510(k)
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The BellySTEP, HeadSTEP, BreastSTEP, ProSTEP, WingSTEP, and ICAST are patient immobilization systems classified as Linear Accelerator Medical Devices. These devices are designed to secure specific body regions—such as the abdomen, head/neck, thorax, hips, extremities, and other targeted areas—during radiotherapy and diagnostic imaging procedures. Their purpose is to ensure precise, reproducible patient positioning for consistent treatment delivery or diagnostic accuracy.
These systems are supplied as reusable medical devices and are intended for use in radiology and radiotherapy settings. Each variant includes baseplates, cushions, and thermoplastic materials tailored to immobilize distinct anatomical regions. The devices are regulated under FDA 510(k) clearance and comply with MDR standards, with no specific sterility requirements noted in the data. They are available in multiple sizes to accommodate different patient anatomies and are designed for repeated use in clinical environments.
Frequently asked questions
Are these immobilization systems designed for single-use or repeated clinical use in radiotherapy and imaging procedures?
The BellySTEP, HeadSTEP, BreastSTEP, ProSTEP, WingSTEP, and ICAST systems are explicitly described as reusable medical devices, meaning they are intended for repeated use in radiology and radiotherapy settings. Their design includes components like baseplates, cushions, and thermoplastic materials that are meant to withstand multiple applications, ensuring consistent patient positioning over time.
What anatomical regions do these devices target, and how do they ensure precise positioning?
Each variant of the STEP series is tailored to immobilize specific body regions: the BellySTEP for the abdomen, HeadSTEP for the head/neck, BreastSTEP for the thorax, ProSTEP for the hips, WingSTEP for extremities, and ICAST for other targeted areas. They achieve precise positioning through baseplates, cushions, and thermoplastic materials, which work together to secure the patient’s body part in a reproducible manner during radiotherapy or diagnostic imaging.
Do these devices require sterilization before use, and if not, how should they be maintained?
The data does not specify sterility requirements for these reusable immobilization systems. However, since they are designed for repeated clinical use, proper cleaning and disinfection protocols should be followed between patients to prevent contamination. The manufacturer’s instructions (not provided here) would outline the recommended cleaning and maintenance procedures to ensure hygiene and longevity.
Are there multiple sizes available to accommodate different patient anatomies?
Yes, the BellySTEP, HeadSTEP, BreastSTEP, ProSTEP, WingSTEP, and ICAST systems are available in multiple sizes to accommodate varying patient anatomies. This modularity ensures that clinicians can select the appropriate variant to achieve a secure and reproducible fit for each patient’s specific body region during treatment or imaging.
What regulatory pathways have these devices undergone, and how does that affect their use in clinical settings?
These devices have been cleared under FDA 510(k) pathways (with a decision labeled as *Substantially Equivalent* under the Radiology advisory committee) and comply with MDR (Medical Device Regulation) standards. This means they have undergone evaluation for safety and effectiveness in their intended use—patient immobilization during radiotherapy and diagnostic imaging—and are authorized for commercial distribution in the U.S. and EU markets, respectively. Clinicians can rely on their regulatory clearance as evidence of compliance with applicable standards.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Bellystep, Headstep, Breaststep, Prostep, Wingstep and Icast, Startseite - IT-V, BellySTEP - IT-V
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K081218 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- IT-V Medizintechnik GmbH
- FDA Applicant
- It-V Medizintechnik, GmbH
Sources (2)
- FDA 510(k) K081218 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 19, 2026