Cleared Traditional

K041715 - INTRACAVITARY MOULD APPLICATOR SET

K041715 is the FDA 510(k) clearance for INTRACAVITARY MOULD APPLICATOR SET by Nucletron Corp.. It is a Class 2 Radiology device (product code JAQ) cleared through the Traditional 510(k) pathway after a 274-day FDA review.

K041715 · Nucletron Corp. · Radiology device
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Optimized for regulatory review, auditing and printing
Mar 2005
Decision
274d
Days
Class 2
Risk

K041715 is an FDA 510(k) clearance for the INTRACAVITARY MOULD APPLICATOR SET, MODEL 189.001. Classified as System, Applicator, Radionuclide, Remote-controlled (product code JAQ), Class II - Special Controls.

Submitted by Nucletron Corp. (Columbia, US). The FDA issued a Cleared decision on March 24, 2005 after a review of 274 days - an extended review cycle.

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 Nucletron Corp. devices

Submission Details

510(k) Number K041715 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 23, 2004
Decision Date March 24, 2005
Days to Decision 274 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
167d slower than avg
Panel avg: 107d · This submission: 274d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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

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