Cleared Traditional

K882939 - NIOBI-X RADIATION REDUCTION FILTER (FDA 510(k) Clearance)

Class I Radiology device.

K882939 · American Canadian Products, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1988
Decision
114d
Days
Class 1
Risk

K882939 is an FDA 510(k) clearance for the NIOBI-X RADIATION REDUCTION FILTER. Classified as Assembly, Tube Housing, X-ray, Diagnostic (product code ITY), Class I - General Controls.

Submitted by American Canadian Products, Inc. (Tampa, US). The FDA issued a Cleared decision on November 4, 1988 after a review of 114 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1760 - 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 American Canadian Products, Inc. devices

Submission Details

510(k) Number K882939 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 13, 1988
Decision Date November 04, 1988
Days to Decision 114 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 slower than avg
Panel avg: 107d · This submission: 114d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code ITY Assembly, Tube Housing, X-ray, Diagnostic
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 892.1760
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.