Rad Source X-Ray Blood Irradiator Model RS-3400
FDA 510(k)EUDAMEDU (US FDA 510(k))
Identifiers
- 510(k) Number
- K082921 FDA 510(k)
- FDA Product Code
- MOT FDA 510(k)
Classification
- Device Class
- U FDA 510(k)
- Advisory Committee
- Unknown FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Rad Source X-Ray Blood Irradiator Model RS-3400 is a medical device classified as an irradiator, blood to prevent graft versus host disease. It employs an x-ray emitter to deliver controlled radiation to blood products, reducing the risk of immune-mediated complications in transfusions. The device is designed to ensure uniform irradiation by rotating blood bags around a fixed emitter using a carousel mechanism. This process is critical in hematopoietic stem cell transplantation and other high-risk transfusion scenarios where graft-versus-host disease (GVHD) mitigation is essential.
The RS-3400 operates as a self-contained unit, eliminating the need for external water cooling systems. It is intended for use in clinical settings such as blood banks, transplant centers, and research laboratories where blood products are prepared or processed. The device is regulated under the FDA 510(k) clearance and complies with the Medical Device Directive (MDD). It is supplied as a reusable medical instrument, requiring proper maintenance and calibration to ensure consistent performance and safety. Storage and handling must adhere to radiation safety protocols to prevent exposure risks.
Frequently asked questions
What is the Rad Source RS-3400 X-Ray Blood Irradiator used for?
The RS-3400 is designed to irradiate blood products with controlled x-rays to reduce the risk of graft-versus-host disease (GVHD) in high-risk transfusions. This is particularly critical in hematopoietic stem cell transplantation and other scenarios where immune-mediated complications from transfusions are a concern. The device ensures uniform radiation exposure by rotating blood bags around a fixed emitter using a carousel system.
How is the RS-3400 supplied and what are its key features?
The RS-3400 is supplied as a reusable medical instrument, meaning it requires regular maintenance and calibration to maintain performance and safety. Unlike some irradiators, it operates as a self-contained unit, eliminating the need for external water cooling systems. This design simplifies installation and reduces operational complexity in clinical settings like blood banks, transplant centers, and research labs.
Is the RS-3400 single-use or reusable, and what does that mean for its use?
The RS-3400 is a reusable device, which means it is intended for repeated use after proper cleaning, maintenance, and calibration. Reusability ensures cost-effectiveness and consistency in performance over time, but it also requires adherence to strict protocols for sterilization and safety checks to prevent contamination or malfunctions. Users must follow manufacturer guidelines to ensure the device remains effective and safe for blood irradiation.
What safety protocols should be followed when storing and handling the RS-3400?
Storage and handling of the RS-3400 must strictly adhere to radiation safety protocols to minimize exposure risks. The device should be stored in a designated, secure area with restricted access, away from unauthorized personnel, especially those who may not be trained in radiation safety. Regular inspections and maintenance checks are essential to ensure the device operates within safe parameters. Additionally, users should follow the manufacturer’s instructions for proper shutdown procedures and shielding to prevent accidental radiation leaks.
What regulatory approvals does the RS-3400 hold, and how does that affect its use?
The RS-3400 has received FDA 510(k) clearance and complies with the Medical Device Directive (MDD), indicating it meets regulatory standards for safety and effectiveness. These approvals confirm that the device has undergone rigorous testing and validation to ensure it performs as intended for its designated purpose—irradiating blood to prevent GVHD. Clinicians and facilities using the device can rely on these approvals to confirm its suitability for clinical applications in blood banks and transplant settings.
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. Sources consulted: RS 3400 Blood Irradiator | Rad Source Technologies, RS 3400 Series | Rad Source Technologies, RS 3400 - Rad Source NDT - PDF Catalogs - DirectIndustry, RS3400 Blood-Irradiator Brochure Mkt-037 Rev3 - Scribd
Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | U | Active |
| FDA 510(k) | United States | FDA_510K | K082921 | U | Active |
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Manufacturer
- Manufacturer
- Rad Source Technologies, Inc.
Sources (2)
- FDA 510(k) K082921 24 fields · synced Oct 1, 2026
- EUDAMED 1 fields · synced May 19, 2026