Cleared Special

K032684 - RAYCELL (FDA 510(k) Clearance)

K032684 · Mds Nordion · Radiology device
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Sep 2003
Decision
28d
Days
-
Risk

K032684 is an FDA 510(k) clearance for the RAYCELL. 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 September 26, 2003 after a review of 28 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 K032684 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 29, 2003
Decision Date September 26, 2003
Days to Decision 28 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
79d faster than avg
Panel avg: 107d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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