K161324 - Raycell Mk2 (FDA 510(k) Clearance)

K161324 is an FDA 510(k) clearance for the Raycell Mk2. Classified as Irradiator, Blood To Prevent Graft Versus Host Disease (product code MOT).

Submitted by Best Theratronics Limited (Ottawa, CA). The FDA issued a Cleared decision on August 12, 2016 after a review of 93 days - within the typical 510(k) review window.

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. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.