Cleared Traditional

K173425 - SRT-100+

K173425 is an FDA 510(k) clearance for SRT-100+, manufactured by Sensus Healthcare, Inc.. The device is a Class 2 Radiology device with product code JAD cleared through the Traditional 510(k) pathway after a 141-day FDA review.

K173425 · Sensus Healthcare, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2018
Decision
141d
Days
Class 2
Risk

K173425 is an FDA 510(k) clearance for the SRT-100+. Classified as System, Therapeutic, X-ray (product code JAD), Class II - Special Controls.

Submitted by Sensus Healthcare, Inc. (Boca Raton, US). The FDA issued a Cleared decision on March 23, 2018 after a review of 141 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.5900 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Sensus Healthcare, Inc. devices

FDA 510(k) Submission Details - K173425

510(k) Number K173425 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
34d slower than avg
Panel avg: 107d · This submission: 141d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JAD Device Classification - Class 2, Special Controls

Product Code JAD System, Therapeutic, X-ray
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.5900
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Peers - JAD System, Therapeutic, X-ray

All 34
Devices cleared under the same product code (JAD) and FDA review panel - the closest regulatory comparables to K173425.
Esteya
K213942 · Nucletron B.V. · Jan 2022
Sensus IORT System
K182641 · Sensus Healthcare, Inc. · Feb 2019
Sensus Healthcare TVM Balloon Applicator
K190255 · Sensus Healthcare, Inc. · Feb 2019
Photoelectric Therapy System
K172080 · Xstrahl, Ltd. · Sep 2017
INTRABEAM 600
K162568 · Carl Zeiss Meditec, AG · Dec 2016
Axxent Electronic Brachytherapy System Model 110 XP 1200
K153570 · Icad, Inc. · Feb 2016