Cleared Traditional

XBeam (v2)

K240671 · Xstrahl, Ltd. · Radiology
Dec 2024
Decision
268d
Days
Class 2
Risk

About This 510(k) Submission

K240671 is an FDA 510(k) clearance for the XBeam (v2), a System, Planning, Radiation Therapy Treatment (Class II — Special Controls, product code MUJ), submitted by Xstrahl, Ltd. (Brownhills, GB). The FDA issued a Cleared decision on December 4, 2024, 268 days after receiving the submission on March 11, 2024. This device falls under the Radiology review panel. Regulated under 21 CFR 892.5050.

Submission Details

510(k) Number K240671 FDA.gov
FDA Decision Cleared SESE
Date Received March 11, 2024
Decision Date December 04, 2024
Days to Decision 268 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code MUJ — System, Planning, Radiation Therapy Treatment
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.5050