VacuumCushions, FeetSupports, LEPS (Lower Extermities Positioning System), CouchStrips

510(k) Number

K212909 ↗

FDA Product Code

IYE

Device Class

Class II

Regulation

21 CFR Part 892.5050

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

• OmniBoard

  Class I

  CE/MDR

• CouchStrip

  Class I

  CE/MDR

• MaxSupport™ S-C MR

  Class I

  CE/MDR

• Vacuum Cushion

  Class I

  CE/MDR

• OmniCouch

  Class I

  CE/MDR

• EasyLock Couchstrip

  Class I

  CE/MDR

See all devices from Macromedics BV →

• What types of procedures is this modular patient positioning system designed for, and why is stability important in these settings?

  The Vacuum Cushions, Feet Supports, LEPS (Lower Extremities Positioning System), and Couch Strips are specifically designed for radiotherapy and radiodiagnostic procedures. Stability is critical in these settings because precise, reproducible positioning of the lower extremities and pelvic region ensures accurate imaging and treatment delivery. Variations in positioning could lead to misalignment, compromising the effectiveness of radiation therapy or diagnostic imaging.

• Are all components of this system reusable, or are there single-use items? How does this affect workflow and cost?

  Within this system, the vacuum cushions and LEPS are reusable, while the feet supports and couch strips are designed for single-use. This distinction allows facilities to balance cost efficiency (by reusing certain components) with hygiene and infection control (by using single-use items where necessary). Clinicians should follow manufacturer guidelines for cleaning and reprocessing reusable parts to maintain functionality and sterility.

• How should this system be stored to ensure it remains functional and sterile, especially for reusable components?

  The manufacturer specifies that this system must be stored according to their instructions to maintain both sterility and functionality. For reusable components like the vacuum cushions and LEPS, this likely includes proper cleaning, disinfection, and packaging to prevent contamination. Single-use items (feet supports and couch strips) should be stored in a way that preserves their integrity until use, avoiding exposure to moisture or physical damage.

• Is this system compatible with MRI machines, or are there any restrictions on its use?

  The system is not MRI-safe, meaning it should not be used in MRI environments. This is explicitly stated in the manufacturer’s instructions, as MRI compatibility requires materials that do not interfere with magnetic fields or generate heat. Clinicians should verify the room’s equipment before use to avoid potential hazards.

• What regulatory pathway was followed for FDA clearance, and what does this mean for clinicians or facilities considering this product?

  This system received FDA 510(k) clearance under the Traditional pathway, classified as Class II under product code IYE. This means the FDA determined it is substantially equivalent to a legally marketed device already on the market. For clinicians or facilities, this indicates that the product has undergone review by the FDA’s Radiology (RA) Advisory Committee and meets established safety and effectiveness standards for use in radiology settings, though they should always refer to the latest labeling for specific instructions.