Cleared Traditional

K954564 - PID-1 PRECISION INTELLIGENT DOSIMETER

K954564 is the FDA 510(k) clearance for PID-1 PRECISION INTELLIGENT DOSIMETER by Gammex, Inc.. It is a Class 2 Radiology device (product code IYE) cleared through the Traditional 510(k) pathway after a 203-day FDA review.

K954564 · Gammex, Inc. · Radiology device
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Apr 1996
Decision
203d
Days
Class 2
Risk

K954564 is an FDA 510(k) clearance for the PID-1 PRECISION INTELLIGENT DOSIMETER. Classified as Accelerator, Linear, Medical (product code IYE), Class II - Special Controls.

Submitted by Gammex, Inc. (Middleton, US). The FDA issued a Cleared decision on April 22, 1996 after a review of 203 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.5050 - the FDA radiology and imaging software oversight framework. 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 Gammex, Inc. devices

Submission Details

510(k) Number K954564 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 02, 1995
Decision Date April 22, 1996
Days to Decision 203 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
96d slower than avg
Panel avg: 107d · This submission: 203d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code IYE Accelerator, Linear, Medical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.5050
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Peers - IYE Accelerator, Linear, Medical

All 317
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