FDA 510(k)

XBeam (v2)

K-Number: K240671 · 2024-12-04

Decision Date2024-12-04

Product CodeMUJ

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

XBeam (v2) is the device name listed in this FDA 510(k) record. The listed applicant is Xstrahl, Ltd.. It received FDA 510(k) clearance on 2024-12-04 under 510(k) number K240671. The device is classified under product code MUJ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the XBeam (v2)?

XBeam (v2) is a medical device that received FDA 510(k) clearance on 2024-12-04. The listed applicant is Xstrahl, Ltd.. The 510(k) number is K240671.

When did XBeam (v2) receive FDA 510(k) clearance?

XBeam (v2) received FDA 510(k) clearance on 2024-12-04, under 510(k) number K240671.

Who is the listed applicant for XBeam (v2)?

The FDA 510(k) record lists Xstrahl, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for XBeam (v2)?

The FDA product code for XBeam (v2) is MUJ.

Other records listing Xstrahl, Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

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