CLAROX Plus (Model VX-100)
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K221417 FDA 510(k)
- FDA Product Code
- IZL 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 CLAROX Plus (Model VX-100) is a portable mobile X-ray system (Device Type: System, X-Ray, Mobile) designed for handheld operation. It generates diagnostic-quality radiographic images of human anatomy, including extremities, and is classified as a Class II medical device under FDA regulations. The device operates with a fixed X-ray tube current and voltage (kVp), restricting its use to specific anatomical regions.
This battery-operated system is intended for use in general-purpose radiography, suitable for adult, pediatric, and neonatal exams. Supplied as a reusable device, it requires qualification and training for operation by a clinician. The CLAROX Plus (Model VX-100) holds FDA 510(k) clearance (K221417) and complies with the Medical Device Directive (MDD). No specific sterility or MRI safety information is provided in the data.
Frequently asked questions
What anatomical regions can the CLAROX Plus (Model VX-100) be used to capture diagnostic images for, and does it support pediatric or neonatal patients?
The CLAROX Plus (Model VX-100) is designed for handheld radiographic imaging of human anatomy, specifically targeting extremities. Due to its fixed X-ray tube settings (kVp and current), it is optimized for these regions only. The device is explicitly intended for general-purpose radiography, making it suitable for imaging adult, pediatric, and neonatal patients, as stated in its description.
Is the CLAROX Plus (Model VX-100) a single-use or reusable device, and what training or qualifications are required to operate it?
The CLAROX Plus (Model VX-100) is a reusable portable X-ray system, meaning it is not designed for single-use disposal. Since it requires specialized operation, the device mandates that only qualified clinicians with appropriate training and certification use it, as outlined in its description.
What regulatory pathways has the CLAROX Plus (Model VX-100) followed, and which regulatory bodies have approved or cleared it?
The CLAROX Plus (Model VX-100) has obtained FDA 510(k) clearance under the number K221417, demonstrating it is classified as substantially equivalent to a predicate device. It also complies with the Medical Device Directive (MDD), indicating its regulatory approval in regions adhering to this directive. The device is classified as Class II under FDA regulations.
How is the CLAROX Plus (Model VX-100) powered, and what limitations should clinicians be aware of regarding its use?
The CLAROX Plus (Model VX-100) is battery-operated, allowing for portable use in various clinical settings. However, its fixed X-ray tube current and voltage (kVp) restrict its diagnostic applications to specific anatomical regions, primarily extremities. Clinicians should note that the device is not intended for imaging other body parts or complex anatomical areas.
Are there any specific storage requirements or considerations for the CLAROX Plus (Model VX-100) to ensure its proper functionality?
The provided data does not specify any unique storage requirements for the CLAROX Plus (Model VX-100) beyond standard handling for a reusable medical device. Since it is battery-operated and portable, it should be stored in a clean, dry environment to prevent damage to its components. No sterility or MRI safety information is provided, so additional precautions may be necessary depending on the clinical setting.
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: VSI CLAROX PLUS USER MANUAL Pdf Download | ManualsLib, CLAROX plus (Model: VX-100) (K221417) — FDA 510(k) | Innolitics, VSI Co., Ltd. VX-100 CLAROX plus - revmedconnect.com
Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K221417 | Class II | Active |
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Manufacturer
- Manufacturer
- VSI Co., Ltd.
Sources (2)
- FDA 510(k) K221417 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 19, 2026