Cleared Traditional

K963497 - GAMMACELL 3000 ELAN, VERSION 1.0 AND GAMMACELL 1000 ELITE, VERSION 1.0 (FDA 510(k) Clearance)

K963497 · Nordion International, Inc. · Radiology device
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Nov 1996
Decision
66d
Days
-
Risk

K963497 is an FDA 510(k) clearance for the GAMMACELL 3000 ELAN, VERSION 1.0 AND GAMMACELL 1000 ELITE, VERSION 1.0. Classified as Irradiator, Blood To Prevent Graft Versus Host Disease (product code MOT).

Submitted by Nordion International, Inc. (Kanata, Ontario, CA). The FDA issued a Cleared decision on November 8, 1996 after a review of 66 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Nordion International, Inc. devices

Submission Details

510(k) Number K963497 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 03, 1996
Decision Date November 08, 1996
Days to Decision 66 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
41d faster than avg
Panel avg: 107d · This submission: 66d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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