LifeRay Intraoral Handheld X-ray System
510(k) K241305
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK241305 | Date5 Jul 2024 | 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- Withdrawn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
- EHD
- Device Class
- Class II
- Regulation
- 21 CFR Part 872.1800
- Advisory Committee
- Dental
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The LifeRay Intraoral Handheld X-ray System is a portable intraoral radiographic device designed for dental imaging. It emits X-rays to capture detailed images of teeth, jaws, and surrounding structures, enabling precise diagnosis of dental conditions such as cavities, gum disease, or bone loss. As classified under X-Ray, Extraoral With Timer, it is engineered for intraoral use, providing high-resolution images essential for clinical decision-making in dental practice.
This system is supplied as a reusable medical device, intended for use in dental settings where portability and ease of operation are critical. It operates within regulatory standards outlined by FDA 510K clearance (K241305) and adheres to 21 CFR Part 872.1800, ensuring compliance with U.S. medical device regulations. The device is not MRI-safe and requires proper handling, storage, and maintenance to preserve performance and safety. It is distributed by Lucas Lifecare, based in Janesville, Wisconsin.
Other devices from Lucas Lifecare
Questions
AI-generated answers, 1 Oct 2026
What is the LifeRay Intraoral Handheld X-ray System used for?
The LifeRay Intraoral Handheld X-ray System is designed specifically for dental imaging. It emits controlled X-rays to capture detailed images of teeth, jaws, and surrounding structures, helping clinicians diagnose dental conditions such as cavities, periodontal disease, or bone loss with precision. Its intraoral design allows for direct placement in the mouth, ensuring accurate and high-resolution imaging essential for effective treatment planning.
Is the LifeRay Intraoral Handheld X-ray System reusable or single-use?
The LifeRay Intraoral Handheld X-ray System is a reusable medical device. It is engineered for repeated use in dental settings, provided it undergoes proper cleaning, maintenance, and sterilization procedures as outlined by Lucas Lifecare to ensure safety and performance. Reusability enhances cost-effectiveness and operational efficiency in clinical environments.
What regulatory approvals does this device hold?
The LifeRay Intraoral Handheld X-ray System holds FDA 510K clearance under the classification of X-Ray, Extraoral With Timer, specifically for intraoral use. It is also compliant with 21 CFR Part 872.1800, adhering to U.S. medical device regulations. The device was reviewed by the Dental (DE) Advisory Committee and granted a Substantially Equivalent (SESE) decision, ensuring it meets established safety and performance standards.
How should the LifeRay Intraoral Handheld X-ray System be stored?
The LifeRay Intraoral Handheld X-ray System requires proper storage to maintain its performance and safety. It should be kept in a clean, dry environment, protected from physical damage, moisture, and extreme temperatures. Storage should follow manufacturer guidelines to prevent contamination and ensure longevity. Additionally, since it is not MRI-safe, it must be stored away from MRI environments to avoid interference or damage.
Does the LifeRay Intraoral Handheld X-ray System come with multiple models or sizes?
The LifeRay Intraoral Handheld X-ray System is available in multiple configurations, as indicated by the listed FEI numbers (e.g., 3013099020, 3003528079, etc.). These variations may correspond to different technical specifications or accessories, but the core functionality remains consistent for intraoral dental imaging. For precise details on specific models or sizes, consulting Lucas Lifecare’s product documentation or support team is recommended.