RadiForce RX440 4MP Color LCD Monitor
510(k) K130070
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK130070 | Date8 Feb 2013 | 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- Withdrawn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
- Full name
- 4MP Color LCD Monitor, Radiforce RX440
- 510(k) Number
- FDA Product Code
- LLZ
- Device Class
- Class II
- Regulation
- 21 CFR Part 892.2050
- Advisory Committee
- Radiology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The RadiForce RX440 is a 4MP Color LCD Monitor designed for radiology applications, providing high-resolution imaging with a 30-inch display. It is classified as a diagnostic imaging monitor, optimized for clear visualization of medical images in clinical settings. The device features a 4-megapixel color display, enabling detailed and accurate representation of radiographic and fluoroscopic images. Its high pixel density reduces the need for multiple smaller screens while maintaining image fidelity.
This monitor is supplied with an adjustable stand offering tilt, swivel, and height adjustments for ergonomic positioning. It incorporates an LED backlight for energy efficiency while maintaining high brightness. The device is intended for single-use or reusable settings, depending on facility protocols, and is regulated under FDA 510(k) clearance (K130070) as substantially equivalent to a predicate device. No specific sterility or MRI safety information is provided in the specifications.
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Questions
AI-generated answers, 1 Oct 2026
What is the RadiForce RX440 4MP LCD Monitor designed for?
The RadiForce RX440 is specifically designed for radiology applications, providing high-resolution imaging to ensure accurate visualization of radiographic and fluoroscopic images. Its 4-megapixel color display delivers detailed clarity, reducing the need for multiple smaller screens while maintaining image fidelity in clinical settings.
How is the RadiForce RX440 supplied and what ergonomic features does it include?
The monitor comes with an adjustable stand that allows for tilt, swivel, and height adjustments, enabling ergonomic positioning to suit individual user preferences and workspace requirements. This flexibility helps reduce user fatigue during prolonged use.
Is the RadiForce RX440 intended for single-use or reusable settings?
The device is versatile and can be used in either single-use or reusable settings, depending on the facility’s protocols and infection control practices. Facilities should follow their established guidelines for cleaning and maintenance to ensure optimal performance and safety.
What type of backlighting does the RadiForce RX440 use, and why is it significant?
The monitor features an LED backlight, which provides energy efficiency while maintaining high brightness levels. This combination ensures that the display remains clear and well-lit without excessive power consumption, making it suitable for continuous use in clinical environments.
Does the RadiForce RX440 have any specific regulatory approvals or classifications?
The RadiForce RX440 is regulated under FDA 510(k) clearance (K130070) and is classified as substantially equivalent to a predicate device. It is intended for diagnostic imaging in radiology and adheres to the standards set by the FDA for such devices.