Cleared Traditional

X80 / RADiant / PhotoElectric Therapy System (RADiant Aura)

K230611 · Xstrahl, Ltd. · Radiology

Jul 2023

Decision

129d

Days

Class 2

Risk

About This 510(k) Submission

K230611 is an FDA 510(k) clearance for the X80 / RADiant / PhotoElectric Therapy System (RADiant Aura), a System, Therapeutic, X-ray (Class II — Special Controls, product code JAD), submitted by Xstrahl, Ltd. (Brownhills, GB). The FDA issued a Cleared decision on July 13, 2023, 129 days after receiving the submission on March 6, 2023. This device falls under the Radiology review panel. Regulated under 21 CFR 892.5900.

Submission Details

510(k) Number	K230611 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 06, 2023
Decision Date	July 13, 2023
Days to Decision	129 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF