Cleared Special

K051065 - RAYCELL X-RAY BLOOD IRRADIATOR

K051065 · Mds Nordion · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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.

FDA 510(k) Submission Details - K051065

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
77d faster than avg
Panel avg: 107d · This submission: 30d
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 14
Devices cleared under the same product code (MOT) and FDA review panel - the closest regulatory comparables to K051065.
SANGRAY
K172087 · Hitachi , Ltd. · Oct 2017
Raycell Mk2
K161324 · Best Theratronics Limited · Aug 2016
RAD SOURCE X-RAY BLOOD IRRADIATOR, MODEL RS-3400
K082921 · Rad Source Technologies, Inc. · Feb 2009
GAMMACELL 1000 ELITE AND GAMMACELL 3000 ELAN
K050963 · Mds Nordion · May 2005
RAYCELL
K032684 · Mds Nordion · Sep 2003
SHIELDED CABINET X-RAY RADIATION SOURCE DEVICE MODEL RS 3000
K974210 · Rad-Source, Inc. · Mar 1998
K051065 · RAYCELL X-RAY BLOOD IRRADIATOR
Download PDF Mds Nordion