510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K963497Substantially Equivalent

Gammacell 3000 Elan, Version 1.0 and Gammacell 1000 Elite, Version 1.0

Nordion International, Inc., Kanata, Ontario, CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K963497 is the FDA 510(k) clearance record for GAMMACELL 3000 ELAN, VERSION 1.0 AND GAMMACELL 1000 ELITE, VERSION 1.0, cleared for Nordion International, Inc. on under FDA product code MOT (Irradiator, Blood To Prevent Graft Versus Host Disease). FDA records list 2 510(k) clearances for Nordion International, Inc., from to . As of , FDA records show no recalls naming K963497.

Clearance record

Decision date
Received
(66 days to decision)
Product code
MOT Irradiator, Blood To Prevent Graft Versus Host Disease
Device class
Unclassified
Review panel
Unknown
Applicant
Nordion International, Inc. 447 March Rd., Kanata, Ontario, CA
510(k) summary
Summary
Third party review
No

Clearances, product code MOT

Trailing 12 months

FDA records hold no clearances under product code MOT in the trailing twelve months.

FDA records show no clearances under product code MOT in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code MOT, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260