Cleared Traditional

K973638 - N.I.T., INC. NEEDLE GUIDING TEMPLATE (FDA 510(k) Clearance)

Class I Radiology device.

K973638 · Avid N.I.T., Inc. · Radiology device
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Dec 1997
Decision
90d
Days
Class 1
Risk

K973638 is an FDA 510(k) clearance for the N.I.T., INC. NEEDLE GUIDING TEMPLATE. Classified as System, Applicator, Radionuclide, Manual (product code IWJ), Class I - General Controls.

Submitted by Avid N.I.T., Inc. (Oldsmar, US). The FDA issued a Cleared decision on December 23, 1997 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.5650 - 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 Avid N.I.T., Inc. devices

Submission Details

510(k) Number K973638 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 24, 1997
Decision Date December 23, 1997
Days to Decision 90 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
17d faster than avg
Panel avg: 107d · This submission: 90d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code IWJ System, Applicator, Radionuclide, Manual
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 892.5650
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.