OPTIONAL REMOTE CONTROL - Rc-115
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K062472 FDA 510(k)
- FDA Product Code
- IZL FDA 510(k)
- Models / Variants
- Rc-115 FDA 510(k)For Portable X-Ray System FDA 510(k)Model Sr-115 FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.1720 FDA 510(k)
- Regulation Number
- 892.1720 FDA 510(k)
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Optional Remote Control Model RC-115 is a handheld device designed as an accessory for the Portable X-Ray System Model SR-115. Classified as a System, X-Ray, Mobile (product code IZL), it enables remote operation of X-ray exposure functions, allowing clinicians to control imaging parameters without direct proximity to the radiation source.
This device is intended for use in radiology settings and is supplied as a reusable accessory. It is not sterile and is not intended for MRI environments. The device received FDA 510(k) clearance under K-number K062472 in 2006, classified as a Class II medical device under special controls. Storage and handling should follow manufacturer guidelines to ensure proper functionality and safety.
Frequently asked questions
What is the RC-115 remote control designed for?
The RC-115 is a handheld remote control accessory specifically designed for the Portable X-Ray System Model SR-115. It allows clinicians to operate X-ray exposure functions—such as activation and parameter adjustments—without standing near the radiation source. This reduces unnecessary radiation exposure to the operator while maintaining precise control over imaging settings.
Is the RC-115 remote control reusable or single-use?
The RC-115 remote control is supplied as a reusable accessory. It is not intended for single-use applications, meaning it can be cleaned, maintained, and used repeatedly across multiple procedures. Proper storage and handling per manufacturer guidelines are essential to ensure its continued functionality and safety.
Does the RC-115 remote control require sterilization?
No, the RC-115 remote control is not sterile and is not intended for sterile procedures. Since it is a reusable device designed for radiology settings, it should be cleaned and disinfected according to the manufacturer’s instructions to prevent contamination between uses. Sterilization is not applicable or recommended.
Can the RC-115 remote control be used in MRI environments?
No, the RC-115 remote control is explicitly not intended for use in MRI environments. Its design and materials are tailored for X-ray systems, and exposure to MRI fields could compromise its performance or safety. Always verify compatibility with the intended imaging modality before use.
What regulatory pathway was followed for the RC-115 remote control?
The RC-115 remote control received FDA 510(k) clearance under K-number K062472 in 2006. It was classified as a Class II medical device under special controls and determined to be substantially equivalent to a predicate device through a traditional review process. The device is categorized under product code IZL (System, X-Ray, Mobile) and falls under the regulatory jurisdiction of the Radiology Advisory Committee.
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: Optional Remote Control, Model Rc-115, for Portable X-ray System, Model ..., K062472 FDA 510(k) - OPTIONAL REMOTE CONTROL | Source-Ray, Inc., Source-Ray Optional Remote Control, RC-115, For Portable…, fda.innolitics.com
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K062472 | Class II | Active |
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Manufacturer
- Manufacturer
- Source-Ray, Inc.
Sources (1)
- FDA 510(k) K062472 24 fields · synced Oct 1, 2026