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Srt-100+

by Sensus Healthcare, Inc.

510(k) K173425

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 5 Oct 2026

Documents

Trust

Unverified

Source FDA 510(k), synced 5 Oct 2026.

Regulatory status

as of registry sync 5 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK173425 Date23 Mar 2018ClearedStatusActive

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
JAD
Device class
Class II
Regulation
21 CFR Part 892.5900
Advisory committee
Radiology
FDA decision
SESE Substantially Equivalent

Related clearances

cited in the FDA summary

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cites

Source: 510k-lineage (choiben314), CC BY 4.0

Overview

AI-generated summary, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The SRT-100+ is a Therapeutic X-Ray System designed for superficial radiotherapy, delivering targeted radiation to treat skin conditions. It is classified as a Class II medical device under FDA regulations, intended for non-invasive treatment of superficial lesions, including non-melanoma skin cancer and keloids. The system employs precise radiation delivery to minimize collateral damage to surrounding tissues while addressing pathological tissue at the treatment site.

This device is supplied as a reusable system, intended for use in clinical settings such as dermatology and oncology practices, as well as hospitals. It operates under sterile conditions during treatment application and requires proper calibration and maintenance per manufacturer guidelines. The SRT-100+ holds FDA 510(k) clearance (K173425) and adheres to regulatory standards outlined in 21 CFR 892.5900. No MRI compatibility or single-use components are specified in the regulatory data.

Devices cleared under K173425

1 device · FDA GUDID

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Devices cleared under K173425
UDI-DISize and differences
Sensus SRT-100+
Sensus Healthcare
SRT-100+10850002237037 —On the market

Similar devices

Other devices filed under FDA product code JAD (System, Therapeutic, X-Ray).

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