XBeam (v2)— 510(k) K240671

Substantially Equivalent

Xstrahl, Ltd.

FDA 510(k) clearance K240671 for XBeam (v2), Substantially Equivalent on 2024-12-04. Applicant: Xstrahl, Ltd.. Device class: 2.

Clearance details

Applicant: Xstrahl, Ltd.
Product code: Code MUJ
Device class: Class 2
Regulation: 21 CFR 892.5050
Advisory panel: Radiology
Date received: 2024-03-11
Decision date: 2024-12-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Brownhills, GB

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.