X80 / RADiant / PhotoElectric Therapy System (RADiant Aura)

FDA 510(k) K230611 · Xstrahl, Ltd.

Substantially Equivalent

510(k) numberK230611

Submission

Device name
X80 / RADiant / PhotoElectric Therapy System (RADiant Aura)
Applicant
Xstrahl, Ltd.
Brownhills, GB
Received
March 6, 2023
Decision date
July 13, 2023
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
JAD – System, Therapeutic, X-Ray
Device class
Class II (moderate risk)
Regulation
21 CFR 892.5900
Specialty
Radiology

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Questions and answers

When was X80 / RADiant / PhotoElectric Therapy System (RADiant Aura) cleared by the FDA?

X80 / RADiant / PhotoElectric Therapy System (RADiant Aura) (K230611) received a 510(k) decision of Substantially Equivalent on July 13, 2023, 129 days after the submission was received.

What is the product code of K230611?

The FDA product code is JAD – System, Therapeutic, X-Ray, a Class II (moderate risk) device regulated under 21 CFR 892.5900.