Cleared Traditional

K062241 - ADJUSTABLE MULTI-CATHETER SOURCE APPLICTOR

K062241 is an FDA 510(k) clearance for ADJUSTABLE MULTI-CATHETER SOURCE APPLICTOR, manufactured by North American Scientific, Inc.. The device is a Class 2 Radiology device with product code JAQ cleared through the Traditional 510(k) pathway after a 99-day FDA review.

K062241 · North American Scientific, Inc. · Radiology device
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Nov 2006
Decision
99d
Days
Class 2
Risk

K062241 is an FDA 510(k) clearance for the ADJUSTABLE MULTI-CATHETER SOURCE APPLICTOR. Classified as System, Applicator, Radionuclide, Remote-controlled (product code JAQ), Class II - Special Controls.

Submitted by North American Scientific, Inc. (Chatsworth, US). The FDA issued a Cleared decision on November 9, 2006 after a review of 99 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.5700 - 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 North American Scientific, Inc. devices

FDA 510(k) Submission Details - K062241

510(k) Number K062241 FDA.gov
FDA Decision Cleared Substantially Equivalent - Abbreviated 510(k) (SESU)
Date Received August 02, 2006
Decision Date November 09, 2006
Days to Decision 99 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
8d faster than avg
Panel avg: 107d · This submission: 99d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JAQ Device Classification - Class 2, Special Controls

Product Code JAQ System, Applicator, Radionuclide, Remote-controlled
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.5700
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 - JAQ System, Applicator, Radionuclide, Remote-controlled

All 134
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