Cleared Traditional

K983337 - ROTTERDAM NASOPHAYRNX MOULD SET

K983337 is an FDA 510(k) clearance for ROTTERDAM NASOPHAYRNX MOULD SET, manufactured by Nucletron Corp.. The device is a Class 2 Radiology device width product code JAQ cleared through the Traditional 510(k) pathway after a 191-day FDA review.

K983337 · Nucletron Corp. · Radiology device
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Apr 1999
Decision
191d
Days
Class 2
Risk

K983337 is an FDA 510(k) clearance for the ROTTERDAM NASOPHAYRNX MOULD SET, PART #089.068. 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 April 2, 1999 after a review of 191 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 K983337 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 23, 1998
Decision Date April 02, 1999
Days to Decision 191 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
84d slower than avg
Panel avg: 107d · This submission: 191d
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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