Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

SRT-100+

K-Number: K173425 · 2018-03-23

ApplicantSensus Healthcare, Inc.
Decision Date2018-03-23
Product CodeJAD
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SRT-100+ is the device name listed in this FDA 510(k) record. The listed applicant is Sensus Healthcare, Inc.. It received FDA 510(k) clearance on 2018-03-23 under 510(k) number K173425. The device is classified under product code JAD. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SRT-100+?

SRT-100+ is a medical device that received FDA 510(k) clearance on 2018-03-23. The listed applicant is Sensus Healthcare, Inc.. The 510(k) number is K173425.

When did SRT-100+ receive FDA 510(k) clearance?

SRT-100+ received FDA 510(k) clearance on 2018-03-23, under 510(k) number K173425.

Who is the listed applicant for SRT-100+?

The FDA 510(k) record lists Sensus Healthcare, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SRT-100+?

The FDA product code for SRT-100+ is JAD.

Other records listing Sensus Healthcare, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K190255Sensus Healthcare TVM Balloon ApplicatorK182665Sensus TPS WorkstationK182641Sensus IORT System

Related Devices (Code: JAD)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K250692GentleBeam (GB1000)Voxel Ray Solutions, LLCK241174INTRABEAM (700); And accessories (INTRABEAM SMART Stand, INTRABEAM SMART Spherical Applicator, INTRABEAM Spherical Sizer Set, INTRABEAM Needle Applicator)Carl Zeiss Meditec, AGK230611X80 / RADiant / PhotoElectric Therapy System (RADiant Aura)Xstrahl, Ltd.K213942EsteyaNucletron B.V.K190255Sensus Healthcare TVM Balloon ApplicatorSensus Healthcare, Inc.K182641Sensus IORT SystemSensus Healthcare, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑