Cleared Traditional

K974210 - SHIELDED CABINET X-RAY RADIATION SOURCE DEVICE MODEL RS 3000

K974210 · Rad-Source, Inc. · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (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.

FDA 510(k) Submission Details - K974210

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
33d slower than avg
Panel avg: 107d · This submission: 140d
Pathway characteristics
Predicate-based equivalence.

MOT Device Classification - Class 0,

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

Regulatory Peers - MOT Irradiator, Blood To Prevent Graft Versus Host Disease

All 14
Devices cleared under the same product code (MOT) and FDA review panel - the closest regulatory comparables to K974210.
RAYCELL X-RAY BLOOD IRRADIATOR
K051065 · Mds Nordion · May 2005
GAMMACELL 1000 ELITE AND GAMMACELL 3000 ELAN
K050963 · Mds Nordion · May 2005
RAYCELL
K032684 · Mds Nordion · Sep 2003
GAMMACELL 3000 ELAN, VERSION 1.0 AND GAMMACELL 1000 ELITE, VERSION 1.0
K963497 · Nordion International, Inc. · Nov 1996
GAMMACELL 3000 ELAN
K952291 · Nordion International, Inc. · Aug 1995
MODEL 109 SERIES BLOOD PRODUCTS IRRADIATORS
K915766 · J. L. Shepherd and Assoc. · Jul 1995
K974210 · SHIELDED CABINET X-RAY RADIATION SOURCE DEVICE MODEL RS 3000
Download PDF FDA Summary Rad-Source, Inc.