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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 a medical device manufactured by Sensus Healthcare, Inc.. It received FDA 510(k) clearance on 2018-03-23 under approval 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. It is manufactured by Sensus Healthcare, Inc.. The 510(k) number is K173425.

When was SRT-100+ approved by the FDA?

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

What company makes SRT-100+?

SRT-100+ is manufactured by Sensus Healthcare, Inc..

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

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

Other Devices by Sensus Healthcare, Inc.

K190255Sensus Healthcare TVM Balloon Applicator K182665Sensus TPS Workstation K182641Sensus IORT System

Related Devices (Code: JAD)

K162568INTRABEAM 600Carl Zeiss Meditec, AG K153570Axxent Electronic Brachytherapy System Model 110 XP 1200Icad, Inc. K172080Photoelectric Therapy SystemXstrahl, Ltd. K190255Sensus Healthcare TVM Balloon ApplicatorSensus Healthcare, Inc. K182641Sensus IORT SystemSensus Healthcare, Inc. K213942EsteyaNucletron B.V.

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.

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