Cleared Traditional

ONCENTRA PROSTATE 4.0 (K112420) - FDA 510(k) Clearance

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K112420 · Nucletron · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2011
Decision
87d
Days
Class 2
Risk

K112420 is an FDA 510(k) clearance for the ONCENTRA PROSTATE 4.0. Classified as System, Applicator, Radionuclide, Remote-controlled (product code JAQ), Class II - Special Controls.

Submitted by Nucletron (Columbia, US). The FDA issued a Cleared decision on November 18, 2011 after a review of 87 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Nucletron devices

Submission Details

510(k) Number K112420 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 23, 2011
Decision Date November 18, 2011
Days to Decision 87 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
20d faster than avg
Panel avg: 107d · This submission: 87d
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

All 50
Devices cleared under the same product code (JAQ) and FDA review panel - the closest regulatory comparables to K112420.
Shielded Applicator Set, Cervical Stop
K151657 · Varian Medical Systems, Inc. · Aug 2015
3D Interstitial Ring Applicator Set 60, 3D Interstitial Ring Applicator Set 90, Ring Applicator Set 45, Ring Applicator Set 60, Ring Applicator Set 90
K150839 · Varian Medical Systems, Inc. · Jul 2015
PLASTIC NEEDLE WITH MANDRIN, 2.0 MM DIAMETER, LENGTH, BLUNT TIP,PLASTIC NEEDLE WITH MANDRIN, 2.0 MM DIAMETER, LENGTH 113
K141624 · Varian Medical Systems, Inc. · Mar 2015
GRAC HIGH DOSE RATE (HDR) REMOTE AFTERLOADING CATHETER
K990753 · Cook, Inc. · May 1999
VRAC HIGH DOSE RATE (HDR) REMOTE AFTERLOADING CATHETER
K981886 · Cook, Inc. · Nov 1998
HIGH DOSE RATE REMOTE AFTERLOADING CATHETER
K923738 · Cook, Inc. · Apr 1993