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FDA 510(k)

XBeam (v2)

K-Number: K240671 · 2024-12-04

ApplicantXstrahl, Ltd.
Decision Date2024-12-04
Product CodeMUJ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

XBeam (v2) is a medical device manufactured by Xstrahl, Ltd.. It received FDA 510(k) clearance on 2024-12-04 under approval 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. It is manufactured by Xstrahl, Ltd.. The 510(k) number is K240671.

When was XBeam (v2) approved by the FDA?

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

What company makes XBeam (v2)?

XBeam (v2) is manufactured by Xstrahl, Ltd..

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

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

Other Devices by Xstrahl, Ltd.

K172080Photoelectric Therapy System K230611X80 / RADiant / PhotoElectric Therapy System (RADiant Aura)

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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.

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