# Sensus SRT-100 Vision

> Active: European Union and United States. Medical device record on deviCERTS, compiled from public registries.

- Canonical page: <https://devicerts.com/devices/sensus-srt-100-vision>
- Manufacturer: [Sensus Healthcare](https://devicerts.com/manufacturers/sensus-healthcare) (United States)
- Device class: Class IIb (EU MDD); Class II (US FDA)
- FDA product code: JAD
- EMDN: Z11019099 VARIOUS RADIOTHERAPY AND RADIOSURGERY INSTRUMENTS - OTHER
- GMDN: Skin-tumour low-voltage therapeutic x-ray system (41023)

## Registrations and authorizations

- **EUDAMED** · CE/MDD · European Union · Basic UDI-DI B-10850002237020 · UDI-DI 10850002237020 · registered 2026-05-19 · status: Withdrawn
- **GUDID** · GUDID listing · United States · UDI-DI 10850002237020 · listed 2018-12-12 · status: Listed (GUDID: in commercial distribution)
- **GUDID** · FDA 510(k) · United States · K150037 · decision 2015-10-16 · decision SESE · status: Active · from GUDID

## Recalls

- Z-1235-2023 · Class II · terminated · initiated 2023-02-10: 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.

## Identity

- Trade name: SRT-100 Vision™ [EUDAMED]; Sensus [FDA GUDID (AccessGUDID)]
- Generic name: Skin-tumour low-voltage therapeutic x-ray system [FDA GUDID (AccessGUDID)]
- Model / reference: SRT-100 Vision™ [EUDAMED]; SRT-100 Vision [FDA GUDID (AccessGUDID)]

## Identifiers

- Primary DI / UDI-DI: 10850002237020 [EUDAMED, FDA GUDID (AccessGUDID)]
- Basic UDI-DI: B-10850002237020 [EUDAMED]
- 510(k) Number: K150037 [FDA GUDID (AccessGUDID)]
- FDA product code: JAD [FDA GUDID (AccessGUDID)]
- EMDN code: Z11019099 [EUDAMED]
- GMDN term: Skin-tumour low-voltage therapeutic x-ray system (41023) [FDA GUDID (AccessGUDID)]

## Classification

- Device class: Class IIb [EUDAMED]; Class II [FDA GUDID (AccessGUDID)]
- Regulation number: 892.5900 [FDA GUDID (AccessGUDID)]
- EU registration type: Legacy device (under a directive) [EUDAMED]
- GUDID distribution status: In Commercial Distribution [FDA GUDID (AccessGUDID)]

## Properties

- Prescription use: Yes [FDA GUDID (AccessGUDID)]
- Serial number: Yes [FDA GUDID (AccessGUDID)]
- Expiration date: Yes [FDA GUDID (AccessGUDID)]
- Manufacturing date: Yes [FDA GUDID (AccessGUDID)]
- Supplied sterile: No [EUDAMED, FDA GUDID (AccessGUDID)]
- Sterilise before use: No [EUDAMED, FDA GUDID (AccessGUDID)]
- Single use: No [FDA GUDID (AccessGUDID)]
- Implantable: No [EUDAMED, FDA GUDID (AccessGUDID)]
- Reusable: No [EUDAMED]
- Contains latex: No [EUDAMED, FDA GUDID (AccessGUDID)]
- Reprocessed single-use device: No [EUDAMED]
- Incorporates a substance derived from human blood or plasma: No [EUDAMED]
- Contains human tissues or cells: No [EUDAMED]
- Contains animal tissues or cells: No [EUDAMED]
- Administering medicine: No [EUDAMED]
- Measuring function: No [EUDAMED]
- Incorporates a medicinal substance: No [EUDAMED]
- Over-the-counter: No [FDA GUDID (AccessGUDID)]
- Convenience kit: No [FDA GUDID (AccessGUDID)]
- Combination product: No [FDA GUDID (AccessGUDID)]
- HCT/P: No [FDA GUDID (AccessGUDID)]
- Premarket exempt: No [FDA GUDID (AccessGUDID)]
- Lot / batch number: No [FDA GUDID (AccessGUDID)]

## Source and citation

- Cite as: Sensus SRT-100 Vision, Sensus Healthcare. deviCERTS medical device catalogue. https://devicerts.com/devices/sensus-srt-100-vision (data as of 2026-11-14).
- Data sources: [FDA GUDID (AccessGUDID)](https://accessgudid.nlm.nih.gov/), [EUDAMED](https://ec.europa.eu/tools/eudamed), [FDA recalls](https://open.fda.gov/apis/device/recall/)
- Registry records last synced: 2026-10-23
- Statuses computed as of: 2026-11-14
- JSON: <https://devicerts.com/devices/sensus-srt-100-vision.json>
- Licence: [CC BY 4.0](https://creativecommons.org/licenses/by/4.0/). The deviCERTS layout and text are licensed under CC BY 4.0. Registry data remain under their source terms: U.S. FDA data (openFDA, AccessGUDID) are U.S. public domain; EUDAMED data are subject to the European Commission reuse terms.
- Attribution: DevicErts, https://devicerts.com/devices/sensus-srt-100-vision
- Compiled by deviCERTS (devicerts.com) from public medical device registries (EUDAMED, European Commission; U.S. FDA via openFDA; AccessGUDID, U.S. National Library of Medicine). deviCERTS is not an official register and gives no regulatory advice: the record in the registry itself prevails.