Cleared Traditional

K010166 - IMAGYN ISOSLEEVE / ISOSTAR NEEDLE SYSTEM

K010166 is an FDA 510(k) clearance for IMAGYN ISOSLEEVE / ISOSTAR NEEDLE SYSTEM, manufactured by Imagyn Medical Technologies, Inc.. The device is a Class 1 Radiology device with product code IWJ cleared through the Traditional 510(k) pathway after a 319-day FDA review.

K010166 · Imagyn Medical Technologies, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2001
Decision
319d
Days
Class 1
Risk

K010166 is an FDA 510(k) clearance for the IMAGYN ISOSLEEVE / ISOSTAR NEEDLE SYSTEM. Classified as System, Applicator, Radionuclide, Manual (product code IWJ), Class I - General Controls.

Submitted by Imagyn Medical Technologies, Inc. (Richland, US). The FDA issued a Cleared decision on December 3, 2001 after a review of 319 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Imagyn Medical Technologies, Inc. devices

FDA 510(k) Submission Details - K010166

510(k) Number K010166 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 18, 2001
Decision Date December 03, 2001
Days to Decision 319 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
212d slower than avg
Panel avg: 107d · This submission: 319d
Pathway characteristics
Predicate-based equivalence.

IWJ Device Classification - Class 1, General Controls

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.

Regulatory Peers - IWJ System, Applicator, Radionuclide, Manual

All 15
Devices cleared under the same product code (IWJ) and FDA review panel - the closest regulatory comparables to K010166.
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