Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

LifeRay Intraoral Handheld X-ray System

K-Number: K241305 · 2024-07-05

ApplicantLucas Lifecare
Decision Date2024-07-05
Product CodeEHD
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

LifeRay Intraoral Handheld X-ray System is a medical device manufactured by Lucas Lifecare. It received FDA 510(k) clearance on 2024-07-05 under approval number K241305. The device is classified under product code EHD. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LifeRay Intraoral Handheld X-ray System?

LifeRay Intraoral Handheld X-ray System is a medical device that received FDA 510(k) clearance on 2024-07-05. It is manufactured by Lucas Lifecare. The 510(k) number is K241305.

When was LifeRay Intraoral Handheld X-ray System approved by the FDA?

LifeRay Intraoral Handheld X-ray System received FDA 510(k) clearance on 2024-07-05, under approval number K241305.

What company makes LifeRay Intraoral Handheld X-ray System?

LifeRay Intraoral Handheld X-ray System is manufactured by Lucas Lifecare.

What is the FDA product code for LifeRay Intraoral Handheld X-ray System?

The FDA product code for LifeRay Intraoral Handheld X-ray System is EHD.

Related Clinical Trials

NCT07531901 Evaluating the Feasibility and Reliability of Using Handheld Nebulizers to Conduct Cough Sensitivity Testing With Citric Acid NOT_YET_RECRUITING NCT07586163 Effectiveness of Clear Aligner Systems in Mixed Dentition Maxillary Transverse Deficiency ACTIVE_NOT_RECRUITING NCT07318623 Comparative Outcomes of Damon Ultima vs Pitts 21 Pro Bracket Systems NOT_YET_RECRUITING NCT07565480 Collection of Training Data for LuminX Probe AI Models NOT_YET_RECRUITING NCT07550361 Validation of Non-Invasive Intracranial Pressure Estimation Using CPMX3 in the Periorbital Vein: A Feasibility Study in Pediatric Patients WITHDRAWN NCT05851326 Low-Energy Ultrasound, Electrical and Magnetic Field Stimulation in Therapy-Resistant Myofascial Pain Syndrome RECRUITING

Other Devices by Lucas Lifecare

K250168Life Ultra 25L Tabletop Mono Chamber Steam Sterilizer

Related Devices (Code: EHD)

K161063EzRay Air (Model VEX-P300)VATECH Co., Ltd. K160458BI IMAGE-X EVOLUTIONRadiotecnologia Industrial S.A. DE C.V. K173319KaVo NOMAD Pro 2 Handheld X-ray SystemAribex K170967Intraskan DC PlusSkanray Technologies Private Limited K163705EzRay Air WVATECH Co., Ltd. K163519RX DCCefla S.C.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑