RadScan Equipment Slicker
by RadScan Medical Equipment, Inc.
510(k) K101350
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK101350 | Date4 Jan 2011 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- KKX
- Device Class
- Class II
- Regulation
- 21 CFR Part 878.4370
- Advisory Committee
- General, Plastic Surgery
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 18 Sep 2026
The RadScan Equipment Slicker is a protective cover and lubricating solution designed to reduce friction and contamination on medical imaging and procedural tables. It functions as a barrier to prevent direct contact between patient positioning surfaces and equipment, while its water-based silicone formulation enhances smoothness for easier patient transfer and positioning.
Supplied as a case of 12 spray bottles (RSS0200SS), the Slicker is intended for single-use application in clinical settings such as CT, angiography, nuclear medicine, and cardiac catheterization labs. Compatible with standard table pads and positioners, it requires no sterilization and is regulated under FDA 510(k) clearance (K101350) as a substantially equivalent device in the Plastic Surgery advisory category. Storage follows standard medical accessory protocols for non-sterile, reusable protective solutions.
From the manufacturer
With a wide range of high-quality industrial manufacturing equipment RadScan produces parts repeatedly and rapidly with accuracy to fill orders of any size.
Slicker Spray can help! Our water-based silicone solution is used to increase the slickness and reduce friction on table pads and positioners to lower the effort required for patient transfer or positioning.
Questions
AI-generated answers, 18 Sep 2026
What clinical settings is the RadScan Equipment Slicker intended for use in?
The RadScan Equipment Slicker is designed for use in clinical environments where patient positioning and imaging require smooth, low-friction surfaces, such as CT scans, angiography labs, nuclear medicine procedures, and cardiac catheterization labs. Its water-based silicone formulation helps reduce friction and contamination between patient positioning surfaces and equipment, making patient transfers and positioning easier.
Is the RadScan Equipment Slicker reusable or single-use, and how is it supplied?
The RadScan Equipment Slicker is intended for single-use application only. It is supplied as a case containing 12 spray bottles (RSS0200SS), each pre-filled with the protective lubricating solution. This ensures a clean, sterile application per use without requiring sterilization.
How should the RadScan Equipment Slicker be stored, and is it sterile?
The RadScan Equipment Slicker is non-sterile and follows standard storage protocols for non-sterile, reusable protective solutions. It should be stored in a clean, dry environment, away from direct sunlight or extreme temperatures, to maintain its integrity until use. Since it’s single-use, storage should align with typical medical accessory guidelines for lubricating solutions.
What types of medical tables or positioners is the RadScan Equipment Slicker compatible with?
The RadScan Equipment Slicker is designed to be compatible with standard medical imaging and procedural tables, including those used in CT, angiography, nuclear medicine, and cardiac catheterization labs. It functions as a barrier on top of existing table pads and positioners, ensuring smoothness and reducing friction during patient movement.
How is the RadScan Equipment Slicker regulated, and what does its FDA clearance mean for users?
The RadScan Equipment Slicker holds FDA 510(k) clearance (K101350), classified under the Plastic Surgery advisory category with a substantially equivalent (SESE) determination. This means it has been reviewed by the FDA as comparable to legally marketed devices in its class, ensuring it meets regulatory standards for safety and effectiveness as a protective lubricating solution for medical tables. Users can rely on this clearance as confirmation of its compliance with U.S. medical device regulations.