Cleared Traditional

K082921 - RAD SOURCE X-RAY BLOOD IRRADIATOR, MODEL RS-3400 (FDA 510(k) Clearance)

K082921 · Rad Source Technologies, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2009
Decision
139d
Days
-
Risk

K082921 is an FDA 510(k) clearance for the RAD SOURCE X-RAY BLOOD IRRADIATOR, MODEL RS-3400. Classified as Irradiator, Blood To Prevent Graft Versus Host Disease (product code MOT).

Submitted by Rad Source Technologies, Inc. (Alpharetta, US). The FDA issued a Cleared decision on February 17, 2009 after a review of 139 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Rad Source Technologies, Inc. devices

Submission Details

510(k) Number K082921 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 01, 2008
Decision Date February 17, 2009
Days to Decision 139 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
32d slower than avg
Panel avg: 107d · This submission: 139d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code MOT Irradiator, Blood To Prevent Graft Versus Host Disease
Device Class -