Photoelectric Therapy System

FDA 510(k) K172080 · Xstrahl, Ltd.

Substantially Equivalent

510(k) numberK172080

Submission

Device name
Photoelectric Therapy System
Applicant
Xstrahl, Ltd.
Brownhills, GB
Received
July 10, 2017
Decision date
September 29, 2017
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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More from Sensus Healthcare

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Questions and answers

When was Photoelectric Therapy System cleared by the FDA?

Photoelectric Therapy System (K172080) received a 510(k) decision of Substantially Equivalent on September 29, 2017, 81 days after the submission was received.

What is the product code of K172080?

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