Cleared Traditional

SRT-100+

K173425 · Sensus Healthcare, Inc. · Radiology
Mar 2018
Decision
141d
Days
Class 2
Risk

About This 510(k) Submission

K173425 is an FDA 510(k) clearance for the SRT-100+, a System, Therapeutic, X-ray (Class II — Special Controls, product code JAD), submitted by Sensus Healthcare, Inc. (Boca Raton, US). The FDA issued a Cleared decision on March 23, 2018, 141 days after receiving the submission on November 2, 2017. This device falls under the Radiology review panel. Regulated under 21 CFR 892.5900.

Submission Details

510(k) Number K173425 FDA.gov
FDA Decision Cleared SESE
Date Received November 02, 2017
Decision Date March 23, 2018
Days to Decision 141 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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