Cleared Traditional

K837346 - MODEL GAMMACELL 1000

K837346 · Atomic Energy of Canada · Radiology device
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Jun 1983
Decision
100d
Days
-
Risk

K837346 is an FDA 510(k) clearance for the MODEL GAMMACELL 1000. Classified as Irradiator, Blood To Prevent Graft Versus Host Disease (product code MOT).

Submitted by Atomic Energy of Canada (Kanata, Ontario, Canada, CA). The FDA issued a Cleared decision on June 24, 1983 after a review of 100 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Atomic Energy of Canada devices

FDA 510(k) Submission Details - K837346

510(k) Number K837346 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 16, 1983
Decision Date June 24, 1983
Days to Decision 100 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
7d faster than avg
Panel avg: 107d · This submission: 100d
Pathway characteristics
Predicate-based equivalence.

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 10
Devices cleared under the same product code (MOT) and FDA review panel - the closest regulatory comparables to K837346.
SHIELDED CABINET X-RAY RADIATION SOURCE DEVICE MODEL RS 3000
K974210 · Rad-Source, Inc. · Mar 1998
GAMMACELL 3000 ELAN, VERSION 1.0 AND GAMMACELL 1000 ELITE, VERSION 1.0
K963497 · Nordion International, Inc. · Nov 1996
IRRADIATOR FOR BIOLOGICAL MATERIALS IBL-437-C
K851828 · Syncor Intl. Corp. · Sep 1985