Data / Medical devices / United States / Rad Source Technologies, Inc.
Rad Source Technologies, Inc.: FDA-registered device maker in Buford, GA, United States, 1 510(k) clearance
Rad Source Technologies, Inc. is registered with the FDA (registration 3002459090) in Buford, GA, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated February 17, 2009. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3002459090
- Address
- 4907 Golden Parkway Suite 400, Buford, GA, United States, 30518
- Owner or operator
- Rad Source Technologies, Inc. (10046519)
- Roles
- Manufacturer
- First device listed
- March 31, 2014
- Registered through
- 2026
- Brand names listed
- Rad Source Technologies, Inc.
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Irradiator, Blood To Prevent Graft Versus Host Disease | MOT | U | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| February 17, 2009 | K082921 | RAD SOURCE X-RAY BLOOD IRRADIATOR, MODEL RS-3400 | MOT | Substantially Equivalent | Rad Source Technologies, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| June 1, 2002 | 26998 | Not yet classified | Terminated | RAD SOURCE RS 3000 Blood Irradiator Three Bag Option | The firm completed a cooling system retrofit to preclude overheating and failure. | accessdata.fda.gov |
Compare with other makers
Updated February 17, 2009. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.