Cleared Traditional

K132889 - FLETCHER CT/MR SHIELDED APPLICATOR SET ...

K132889 is an FDA 510(k) clearance for FLETCHER CT/MR SHIELDED APPLICATOR SET ..., manufactured by Nucletron B.V.. The device is a Class 2 Radiology device with product code JAQ cleared through the Traditional 510(k) pathway after a 163-day FDA review.

K132889 · Nucletron B.V. · Radiology device
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Optimized for regulatory review, auditing and printing
Feb 2014
Decision
163d
Days
Class 2
Risk

K132889 is an FDA 510(k) clearance for the FLETCHER CT/MR SHIELDED APPLICATOR SET (6 MM) FLETCHER CT/MR SHIELDED APPLICA.... Classified as System, Applicator, Radionuclide, Remote-controlled (product code JAQ), Class II - Special Controls.

Submitted by Nucletron B.V. (Veenendaal, NL). The FDA issued a Cleared decision on February 26, 2014 after a review of 163 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 B.V. devices

FDA 510(k) Submission Details - K132889

510(k) Number K132889 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 16, 2013
Decision Date February 26, 2014
Days to Decision 163 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
56d slower than avg
Panel avg: 107d · This submission: 163d
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 122
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