Cleared Special

K051065 - RAYCELL X-RAY BLOOD IRRADIATOR (FDA 510(k) Clearance)

K051065 · Mds Nordion · Radiology device
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May 2005
Decision
30d
Days
-
Risk

K051065 is an FDA 510(k) clearance for the RAYCELL X-RAY BLOOD IRRADIATOR. 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 26, 2005 after a review of 30 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 K051065 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 26, 2005
Decision Date May 26, 2005
Days to Decision 30 days
Submission Type Special
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
77d faster than avg
Panel avg: 107d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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