Sensus Healthcare Superficial X-Ray Radiation Therapy System with Ultrasonic Imaging
FDA 510(k)FDA UDIEUDAMEDClass II (US FDA 510(k))
Identity
- Trade Name
- Sensus FDA UDI
- Generic Name
- Skin-tumour low-voltage therapeutic x-ray system FDA UDI
- Device Name
- Superficial Radiation Therapy System EUDAMED
- Model / Reference
- SRT-100 EUDAMEDFDA UDISRT-100™ EUDAMED
Identifiers
- Primary DI / UDI-DI
- 10850002237013 EUDAMEDFDA UDI
- Basic UDI-DI
- B-10850002237013 EUDAMED
- FDA Product Code
- JAD FDA 510(k)FDA UDI
- EMDN Code
- Z11019099 VARIOUS RADIOTHERAPY AND RADIOSURGERY INSTRUMENTS - OTHER EUDAMED
- GMDN Term
- Skin-tumour low-voltage therapeutic x-ray system FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA 510(k)FDA UDI
- Legislation / Framework
- 21 CFR Part 892.5900 FDA 510(k)
- Regulation Number
- 892.5900 FDA 510(k)FDA UDI
- Market of Registration
- Denmark EUDAMED
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
Yes
Manufacturing Date
Yes
The Sensus Healthcare Superficial X-Ray Radiation Therapy System with Ultrasonic Imaging is a Therapeutic X-Ray System designed for superficial radiation therapy. It delivers targeted radiation doses to treat skin conditions and superficial tumors while incorporating real-time ultrasonic imaging to enhance precision and monitoring during treatment sessions.
This system is intended for use in radiology settings and is supplied as a reusable medical device. It operates under FDA 510(k) clearance and conforms to the Medical Device Directive (MDD), with multiple registration numbers (e.g., 3009732568) indicating compliance with regulatory requirements. The device is classified as Class II under the FDA’s regulatory framework and is intended for professional use by trained personnel in controlled clinical environments.
Frequently asked questions
What types of skin conditions or superficial tumors is this system designed to treat, and how does the ultrasonic imaging help during treatment?
The Sensus Healthcare Superficial X-Ray Radiation Therapy System is specifically designed for treating skin conditions and superficial tumors through targeted radiation. The integrated ultrasonic imaging provides real-time visualization, allowing clinicians to precisely monitor the treatment area, adjust positioning, and ensure accurate delivery of the radiation dose while minimizing exposure to surrounding healthy tissue.
Is this device single-use or reusable, and what maintenance or cleaning procedures should be followed?
This system is supplied as a reusable medical device, intended for professional use in controlled clinical environments. Since it is reusable, proper cleaning, sterilization, and maintenance procedures must be followed as per manufacturer guidelines to ensure safety, functionality, and compliance with regulatory standards. Always refer to the device’s operational manual for specific instructions.
Where is this device primarily used, and who operates it?
The Sensus Healthcare Superficial X-Ray Radiation Therapy System is intended for use in radiology settings, where trained and qualified personnel—such as radiation oncologists, radiologists, or certified radiation therapists—administer treatment. Its design ensures precision for superficial radiation therapy under professional supervision.
How do I verify the regulatory compliance of this device, particularly in terms of FDA and EU standards?
This device holds FDA 510(k) clearance (K150037) and complies with the Medical Device Directive (MDD) in the EU. Its registration numbers (e.g., 3009732568) confirm regulatory filing and classification as a Class II device under FDA guidelines. Always cross-reference these details with official databases or manufacturer documentation for the most current compliance status.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K150037 | Class II | Active |
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Manufacturer
- Manufacturer
- Sensus Healthcare
Sources (3)
- FDA 510(k) K150037 24 fields · synced Sep 18, 2026
- FDA UDI ebc0a2a0-cea4-4c61-814a-90ff8dc1a112 33 fields · synced May 30, 2026
- EUDAMED c20c147a-ac65-48c5-adc3-815b0d73bc3a 61 fields · synced Jul 28, 2026