Cleared Special

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

K161324 · Best Theratronics Limited · Radiology device
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Optimized for regulatory review, auditing and printing
Aug 2016
Decision
93d
Days
-
Risk

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.

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Submission Details

510(k) Number K161324 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 11, 2016
Decision Date August 12, 2016
Days to Decision 93 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
14d faster than avg
Panel avg: 107d · This submission: 93d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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