Cleared Traditional

Photoelectric Therapy System

K172080 · Xstrahl, Ltd. · Radiology
Sep 2017
Decision
81d
Days
Class 2
Risk

About This 510(k) Submission

K172080 is an FDA 510(k) clearance for the Photoelectric Therapy System, 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 September 29, 2017, 81 days after receiving the submission on July 10, 2017. This device falls under the Radiology review panel. Regulated under 21 CFR 892.5900.

Submission Details

510(k) Number K172080 FDA.gov
FDA Decision Cleared SESE
Date Received July 10, 2017
Decision Date September 29, 2017
Days to Decision 81 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code JAD — System, Therapeutic, X-ray
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.5900

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