Cleared Traditional

K974210 - SHIELDED CABINET X-RAY RADIATION SOURCE DEVICE MODEL RS 3000 (FDA 510(k) Clearance)

K974210 · Rad-Source, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1998
Decision
140d
Days
-
Risk

K974210 is an FDA 510(k) clearance for the SHIELDED CABINET X-RAY RADIATION SOURCE DEVICE MODEL RS 3000. Classified as Irradiator, Blood To Prevent Graft Versus Host Disease (product code MOT).

Submitted by Rad-Source, Inc. (Coral Springs, US). The FDA issued a Cleared decision on March 30, 1998 after a review of 140 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, Inc. devices

Submission Details

510(k) Number K974210 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 10, 1997
Decision Date March 30, 1998
Days to Decision 140 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
33d slower than avg
Panel avg: 107d · This submission: 140d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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