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Sensus SRT-100+

by Sensus Healthcare

Sensus SRT-100+ is a skin-tumour low-voltage therapeutic x-ray system (FDA Class II; FDA product code JAD, System, Therapeutic, X-Ray) made by Sensus Healthcare, cleared under FDA 510(k) K173425 on 23 Mar 2018 and listed in FDA GUDID since 12 Dec 2018 (UDI-DI 10850002237037), active as of 23 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

510(k) K173425

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number10850002237037 UDI-DI Date12 Dec 2018ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK173425 Date23 Mar 2018DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K173425 decided 23 Mar 2018 Active
  • FDA GUDID UDI-DI 10850002237037 listed 12 Dec 2018 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K173425
  2. Listed FDA GUDID 10850002237037

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Sensus
Generic name
Skin-tumour low-voltage therapeutic x-ray system
Model / reference
SRT-100+
Primary DI / UDI-DI
10850002237037
510(k) Number
FDA product code
JAD
GMDN term
Skin-tumour low-voltage therapeutic x-ray system
Device class
Class II
Regulation number
892.5900
GUDID distribution status
In Commercial Distribution

Related devices

Category: Skin-tumour low-voltage therapeutic x-ray system

Similar devices

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

Other devices from Sensus Healthcare

See all devices from Sensus Healthcare →

Properties

  • Prescription use
  • Serial number
  • Expiration date
  • Manufacturing date
Other properties (11, all answered No)