Cleared Traditional

K010166 - IMAGYN ISOSLEEVE / ISOSTAR NEEDLE SYSTEM (FDA 510(k) Clearance)

Class I Radiology device.

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

Submission Details

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.

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.