# K974210: Shielded Cabinet X-Ray Radiation Source Device Model RS 3000

- Pathway: 510(k) (Traditional)
- Applicant: Rad-Source, Inc.
- Decided: Mar 30, 1998 after 140 days
- Product code: MOT (Irradiator, Blood To Prevent Graft Versus Host Disease)
- Device class: U
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K865027 (1987). 1 ancestor in all.
4 later devices descend from it; 2 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K865027: Irradiator for Biological Materials, Ibl-137C, Cis-Us, Inc. (1987) Summary page 1.

## Most influential descendants
- K082921: Rad Source X-Ray Blood Irradiator, Model RS-3400 (2009), 2 descendants of its own
- K172087: Sangray (2017), 1 descendant of its own
- K201177: RadGil2 (2020), 0 descendants of its own
- K032684: Raycell (2003), 0 descendants of its own

## Recalls of this device
- Jun 1, 2002 · Not classified · Z-0745-04: The firm completed a cooling system retrofit to preclude overheating and failure.

## Indications for use
The RS 3000 Shielded Cabinet X-ray Radiation Source is intended for the irradiation of blood or blood products packaged in transfusion bags in accordance with “Recommendations Regarding License Amendments and Procedures for Gamma Irradiation of Blood Products” (22 July 1993 memorandum from Acting Director, Office of Blood Research and Review, Center for Biologics Evaluation and Research, FDA to all registered blood establishments) when irradiation to reduce the risk of Graft Versus Host Disease is indicated.

Source page: https://510kreport.com/device/K974210
Methodology: https://510kreport.com/methodology