Cleared Special

K161324 - Raycell Mk2

K161324 · Best Theratronics Limited · Radiology device
Download Printable Device Report (PDF)
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.

View all Best Theratronics Limited devices

FDA 510(k) Submission Details - K161324

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
14d faster than avg
Panel avg: 107d · This submission: 93d
Pathway characteristics
Modification to existing cleared device.

MOT Device Classification - Class 0,

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

Regulatory Peers - MOT Irradiator, Blood To Prevent Graft Versus Host Disease

All 8
Devices cleared under the same product code (MOT) and FDA review panel - the closest regulatory comparables to K161324.
RadGil2
K201177 · R3 X-Ray L.L.C · Aug 2020
Raycell MK1
K181737 · Best Theratronics Limited · Jan 2019
SANGRAY
K172087 · Hitachi , Ltd. · Oct 2017
RAYCELL X-RAY BLOOD IRRADIATOR
K051065 · Mds Nordion · May 2005
GAMMACELL 1000 ELITE AND GAMMACELL 3000 ELAN
K050963 · Mds Nordion · May 2005
SHIELDED CABINET X-RAY RADIATION SOURCE DEVICE MODEL RS 3000
K974210 · Rad-Source, Inc. · Mar 1998