Cleared Traditional

K952291 - GAMMACELL 3000 ELAN

K952291 · Nordion International, Inc. · Radiology device
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Aug 1995
Decision
101d
Days
-
Risk

K952291 is an FDA 510(k) clearance for the GAMMACELL 3000 ELAN. Classified as Irradiator, Blood To Prevent Graft Versus Host Disease (product code MOT).

Submitted by Nordion International, Inc. (Washington, US). The FDA issued a Cleared decision on August 25, 1995 after a review of 101 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 Nordion International, Inc. devices

FDA 510(k) Submission Details - K952291

510(k) Number K952291 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 16, 1995
Decision Date August 25, 1995
Days to Decision 101 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
6d faster than avg
Panel avg: 107d · This submission: 101d
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

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