Skip to content

Sensus SRT-100 Vision

by Sensus Healthcare

Ref SRT-100 Vision™

Sensus SRT-100 Vision is a skin-tumour low-voltage therapeutic x-ray system (EU MDD Class IIb; FDA Class II; FDA product code JAD, System, Therapeutic, X-Ray) made by Sensus Healthcare, registered in EUDAMED on 19 May 2026 (Basic UDI-DI B-10850002237020), cleared under FDA 510(k) K150037 on 16 Oct 2015 and listed in FDA GUDID since 12 Dec 2018 (UDI-DI 10850002237020), withdrawn (EUDAMED), active (FDA 510(k)) as of 23 Oct 2026. One FDA recall is linked to it.

Active Active in United States. Withdrawn in European Union. Also listed in GUDID (US).

CE MDD, withdrawn 510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K150037

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-10850002237020 Basic UDI-DI 10850002237020UDI-DIDate19 May 2026RegisteredStatusWithdrawn
United StatesGUDID listing GUDID Number10850002237020 UDI-DI Date12 Dec 2018ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK150037 Date16 Oct 2015DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-10850002237020 registered 19 May 2026 Withdrawn
  • FDA 510(k) K150037 decided 16 Oct 2015 Active
  • FDA GUDID UDI-DI 10850002237020 listed 12 Dec 2018 Listed

Recalls

1 recall · FDA

    • Terminated Z-1235-2023 FDA Class II initiated 10 Feb 2023

    When the user pauses the beam delivery, the dose timer is reset (to zero), and as a result may deliver an unexpected dose to the patient.

Timeline

4 dated events

  1. Cleared FDA 510(k) K150037
  2. Listed FDA GUDID 10850002237020
  3. Recall initiated FDA recalls Z-1235-2023
  4. Registered EUDAMED B-10850002237020

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Withdrawn
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
SRT-100 Vision™ EUDAMED
Sensus GUDID
Generic name
Skin-tumour low-voltage therapeutic x-ray system
Model / reference
SRT-100 Vision™ EUDAMED
SRT-100 Vision GUDID
Primary DI / UDI-DI
10850002237020
Basic UDI-DI
B-10850002237020
510(k) Number
FDA product code
JAD
EMDN code
Z11019099 Various radiotherapy and radiosurgery instruments - other
GMDN term
Skin-tumour low-voltage therapeutic x-ray system
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
892.5900
EU registration type
Legacy device (under a directive)
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
SRT-100 Vision™
GUDID
SRT-100 Vision
Device classEUDAMED
Class IIb
GUDID
Class II

Device class is stated on each registry's own scale: Class IIb in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

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

Similar devices in this category

Other devices filed under VARIOUS RADIOTHERAPY AND RADIOSURGERY INSTRUMENTS - OTHER.

Other devices from Sensus Healthcare

See all devices from Sensus Healthcare →

Properties

  • Prescription use
  • Serial number
  • Expiration date
  • Manufacturing date
Other properties (19, all answered No)