Cleared Traditional

LifeRay Intraoral Handheld X-ray System

K241305 · Lucas Lifecare · Radiology

Jul 2024

Decision

57d

Days

Class 2

Risk

About This 510(k) Submission

K241305 is an FDA 510(k) clearance for the LifeRay Intraoral Handheld X-ray System, a Unit, X-ray, Extraoral With Timer (Class II — Special Controls, product code EHD), submitted by Lucas Lifecare (Janesville, US). The FDA issued a Cleared decision on July 5, 2024, 57 days after receiving the submission on May 9, 2024. This device falls under the Radiology review panel. Regulated under 21 CFR 872.1800.

Submission Details

510(k) Number	K241305 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 09, 2024
Decision Date	July 05, 2024
Days to Decision	57 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF