Cleared Traditional

K963497 - GAMMACELL 3000 ELAN, VERSION 1.0 AND GAMMACELL 1000 ELITE, VERSION 1.0

K963497 · Nordion International, Inc. · Radiology device

Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)

Optimized for regulatory review, auditing and printing

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.

FDA 510(k) Submission Details - K963497

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
Combination Product	No
PCCP Authorized	No

Regulatory Context

Review time vs. panel average

41d faster than avg

Panel avg: 107d · This submission: 66d

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 K963497.

GAMMACELL 1000 ELITE AND GAMMACELL 3000 ELAN

K050963 · Mds Nordion · May 2005

RAYCELL

K032684 · Mds Nordion · Sep 2003

SHIELDED CABINET X-RAY RADIATION SOURCE DEVICE MODEL RS 3000

K974210 · Rad-Source, Inc. · Mar 1998

GAMMACELL 3000 ELAN

K952291 · Nordion International, Inc. · Aug 1995

MODEL 109 SERIES BLOOD PRODUCTS IRRADIATORS

K915766 · J. L. Shepherd and Assoc. · Jul 1995

MODEL 143 SERIES BLOOD PRODUCT IRRADIATORS

K915767 · J. L. Shepherd and Assoc. · Jul 1995

FDA 510(k) Resources - Radiology

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

Manufacturer of K963497

Nordion International, Inc.

Kanata, Ontario · CA

GRANT MALKOSKE

Regulatory profile

2 submissions 2 cleared

100% clearance rate · Active in Radiology

View all devices by Nordion International, Inc. →

About This 510(k) Record

This record restructures FDA 510(k) public data into device-level regulatory intelligence - enabling comparison across product codes, clearance pathways, review times and manufacturer patterns.

Classification enrichment, manufacturer tracking and cross-device links are added to support regulatory research and predicate analysis workflows.

Sourced from FDA 510(k) public files . FDA decision: November 8, 1996. Record added to 510k Database: March 2026. Enriched with classification and manufacturer data: September 2026.

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