Cleared Special

K050963 - GAMMACELL 1000 ELITE AND GAMMACELL 3000 ELAN (FDA 510(k) Clearance)

K050963 · Mds Nordion · Radiology device
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May 2005
Decision
32d
Days
-
Risk

K050963 is an FDA 510(k) clearance for the GAMMACELL 1000 ELITE AND GAMMACELL 3000 ELAN. Classified as Irradiator, Blood To Prevent Graft Versus Host Disease (product code MOT).

Submitted by Mds Nordion (Ottawa, CA). The FDA issued a Cleared decision on May 20, 2005 after a review of 32 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

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Submission Details

510(k) Number K050963 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 18, 2005
Decision Date May 20, 2005
Days to Decision 32 days
Submission Type Special
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
75d faster than avg
Panel avg: 107d · This submission: 32d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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